In the latest episode of the OIS Podcast, host Dr. Robert Rothman engages in a captivating dialogue with Dr. Prasad Sunkara, CEO of Eyegenex.Key points discussed in the episode:Prasad's multifaceted background spanning agricultural sciences to pharmaceuticals.Eyegenex's pioneering work in gene and peptide therapies for ophthalmic conditions.The personal journey and insights driving Prasad's commitment to advancing ophthalmology.For a deep dive into this thought-provoking conversation, tune in to the OIS Podcast and explore the forefront of ophthalmic innovation.

 This panel discussion on startup commercial strategy explores key elements and insights from industry leaders, Paul Bresge, Aziz Mottiwala, Todd Pinkney, Cari Stone and Adam Szaronos, offering a comprehensive view of the journey from regulatory approval to commercialization. Beth Marsh, Lead of Sales and Marketing at Apellis, sets the stage by emphasizing the importance of early consideration of commercial strategy. Key topics covered in the discussion include:Early Commercial StrategyElements of Robust StrategyRaising Institutional FundingEvolution of StrategiesFuture AnticipationDon't miss out – listen now for a comprehensive view of navigating the complexities of startup success!

OIS Podcast host Carey Powers speaks with Dr. Adrienne Graves and Dr. Barbara Wirostko on 'Maximizing the Value of Your Board of Director' live from OIS XIII.Dr. Graves and Dr. Wirostko share valuable insights on:* Building effective boards* Significance of diversity* CEO and board member communications* Navigating decision-making* Board dynamics* Strategic collaboration This episode is a must-listen for CEOs and founders navigating the intricacies of leadership and strategic decision-making. Tune in now.

In this episode of the OIS Podcast, host Dr. Firas Rahhal, along with expert panelists, Dr. Robert Bhisitkul, Dr. Alan Franklin and Dr. Paul Karpecki at OIS XIII, takes listeners on a deep dive into the transformative landscape of oral therapies in retina treatment, challenging the conventional approach dominated by eye injections. Tune in as they explore the groundbreaking realm of oral treatments and shed light on their novelty in retinal care.The discussions are comprehensive, covering key aspects such as:•  Novelty in Retina Treatment•  Three-Step Improvement and Long-Term Vision Protection•  Optimism for Prevention and Early Intervention•  Clinical Trial Parameters and Market Potential•  Diverse Mechanisms in FocusDon't miss out on this enlightening episode that explores the dynamic landscape of oral therapies, offering a fresh perspective on their potential to revolutionize the field of ophthalmology. Stay informed and engaged with OIS XIII discussions, as experts discuss the exciting possibilities that oral therapies bring to the forefront of retinal treatment.

ViaLase, a clinical stage medical technology company located in Aliso Viejo, CA is focused on disrupting the conventional glaucoma treatment paradigm with the introduction of a truly noninvasive image-guided femtosecond laser treatment that enhances glaucoma patient care.With a leadership team that has vast experience developing, designing, manufacturing, and commercializing the first femtosecond lasers for ophthalmic surgery for refractive and cataract patients, ViaLase is now bringing that expertise and innovation to glaucoma patients.In this episode, Chief Commercialization Officer, Shawn O’Neil chats with OIS host Dr. Rob Rothman and discusses his successful product launches and instrumental contributions to ViaLase's commercialization strategy, their unique reimbursement strategy, the treatment's durability over time, enhancing its long-term impact, and much more.Tune in and see how ViaLase plans to bring this revolutionary treatment to glaucoma patients across the globe.ResourcesViaLase: https://www.vialase.comSean O’Neil: LinkedInRobert Rothman, MD ois.net/robert-rothman-md

Opthea, an Australian based biopharmaceutical company is dedicated to transforming retinal disease treatments and elevating patients' vision and quality of life. Join Firas Rahal, MD, in a captivating episode as he engages with Opthea's Founder and Chief Innovation Officer, Megan Baldwin, PhD.Explore the compelling journey from oncology to ophthalmology, unraveling strategic decisions, navigating competitive landscapes, and achieving triumphs in clinical trials. Dr. Baldwin unfolds her remarkable career trajectory, from a PhD at the University of Melbourne to pivotal roles at Genentech and the Ludwig Institute for Cancer Research.Tune in for exclusive insights, including:Opthea's strategic approach to revolutionizing eye careClinical Trials: A deep dive into their success and impactComparison with Other Drugs: Differentiating factors and unique contributionsFuture Directions: Exploring new horizons and clinical opportunitiesCommercialization Timeline: Anticipated milestones and FDA approval strategiesListen now for a compelling journey through Opthea's vision as they continue to shape the landscape of ophthalmological advancements.Opthea: Opthea.comMegan Baldwin, PhD: LinkedInFiras Rahal, MD ois.net/robert-rothman-md

Harrow isn’t a household name (yet), but eye care professionals have trusted its products for over a decade.The Nashville-based company produces Dexycu, an intraocular steroid; Iopidine for intraocular pressure control; and most recently, five Novartis products that Harrow acquired in December 2022.Rob Rothman, MD, caught up with Harrow founder and CEO Mark Baum to find out how he grew the company from worse than nothing—he acquired, restructured, and reorganized a company in bankruptcy in 2011—to a publicly traded organization with an enterprise value of $750 million.Baum describes Harrow as a “consortium of entrepreneurs.” That consortium includes:Eton Pharmaceuticals, developing products to treat rare diseaseSurface Ophthalmics, developing preservative-free products to treat dry eye disease and post-operative painMelt Pharmaceuticals, which produces MKO Melt, an FDA-approved analgesicHarrow built its business off compounded medications. By meeting needs of physicians in that way, it grew from zero to over 10,000 customers in a relatively short time.Looking ahead, Baum wants to build Harrow’s portfolio and its brand recognition, all while abiding by the company’s mission: to give patients access to affordable ophthalmic medications.Listen to the podcast today to discover:More about Baum’s career path, including his background as a lawyer and investor, his move into business, and the event that prompted him to reorganize and restructure what is now Harrow.Harrow’s corporate philosophy and why Baum considers the company a consortium of entrepreneurs.How Harrow grew from zero to over 10,000 customers in a few years.The secret to Harrow’s success, including how it profits from smaller, but no less important, assets.What’s next for Harrow, including the upcoming launch of Vevye, a dry eye drop based on Novaliq’s proprietary EyeSol water-free technology.How Harrow plans to grow within the next five years, and whether that includes developing its own products.ResourcesHarrow:                       harrow.comMark Baum:                marklbaum.com and on LinkedInRob Rothman, MD      ois.net/robert-rothman-md

Endogena Therapeutics has developed a novel approach to regenerative medicine that’s not only scientifically compelling, but practical.Endogena’s technology unlocks the body’s own stem cells for controlled tissue repair by small molecules. Its products use a dosing schedule that could move easily into the system already in place for intravitreal injections.CEO Matthias Steger, PhD, MBA, sat down with retina specialist Firas Rahhal, MD, to discuss the Endogena approach in depth. They also discuss the compelling results seen so far in both animal models and in patients.The company’s lead candidate is being developed to treat retinitis pigmentosa. The product has received Orphan Drug and Fast Track Designation from the FDA and is moving through Phase IIa clinical trials. Dr. Steger says the company expects to have data to share in early 2024. It’s also submitting an investigational new drug (IND) application for an age-related macular degeneration treatment later this month.Listen to the podcast today to discover:The “serendipitous discoveries” that moved Dr. Steger’s career from applied science to financial analyst to regenerative medicine start-up cofounder.The stem cell approach that Dr. Steger and team are applying to Endogena products and how it differs from implanted stem cell programs.How Endogena applies its novel drug discovery approach to neurodegenerative retinal disease by rebuilding photoreceptors.The type and location of retinal stem cells used for Endogena treatments.The types of molecules used to stimulate or induce an effect from the stem cells.The incredible results the technology produced in mice—regenerating the outer retinal layer “nearly back to normal” and regenerating the rods and cones.The dosing schedule for the RP product and what happens after dosing is complete.How Endogena plans to fund its current and upcoming programs. Where has the funding come from to date? And for upcoming clinical trials?ResourcesEndogena Therapeutics          https://endogena.comFiras Rahhal, MD                     https://ois.net/firas-m-rahhal-md

“You can see and feel a buzz within the company right now,” said Andrew Stewart, President, Global Pharmaceuticals and International Consumer, at Bausch + Lomb.Bausch + Lomb’s current momentum stems not only from new leadership, but also from recent collaborations, partnerships, and acquisitions.Stewart and Yehia Hashad, MD, Executive Vice President of Research & Development and Chief Medical Officer, join host Paul Karpecki, OD, to discuss these activities. Miebo, the first-in-class dry eye asset for the treatment of evaporative dry eye, tops the list.Looking ahead, Stewart and Dr. Hashad said the company is lasering its focus to tackle more unmet medical needs in eye care. The company intends to build on its legacy of innovation in drug delivery, in MOAs, and in developing new molecular entities.What’s next for the most recognized name in eye care?Topics discussed include:Why Stewart shifted into commercial from R&D, and why Dr. Hashad moved from clinical practice to R&D.How Bausch + Lomb leadership is looking at the future for a company with a 170-year legacy.Bausch + Lomb’s holistic approach to dry eye disease and treatment.The company’s thinking behind acquiring the rights from Novaliq to pursue development of what is now Miebo.The importance of addressing unmet needs with respect to the Bausch pipeline.What excites Dr. Hashad and Stewart about the company right now.Where they would like to see Bausch + Lomb in the next three to five years, including for Miebo, for ocular surface disease treatments, and for eye care.ResourcesMiebo                         https://www.miebo.comAndrew Stewart          https://www.bausch.com/about-bausch-lomb/leadership-teamYehia Hashad, MD       https://www.bausch.com/about-bausch-lomb/leadership-teamPaul Karpecki, OD       https://ois.net/paul-karpecki-od

OIS Podcast host Carey Powers caught up with four ophthalmology execs and one principal investigator to talk about some of the most exciting developments in retina R&D.Her guests include:Houman David Hemmati, MD, PhD, Cofounder and Chief Medical Officer of Optigo Biotherapeutics   Michael Tsipursky, MD, CEO and Cofounder of Revive BiotechMichael Singer, MD, Clinical Professor of Ophthalmology at University of Texas Health Science Center, Director of Clinical Research at Medical Center Ophthalmology Associates, and Principal Investigator for Unity Biotechnology’s BEHOLD trialSamarendra Mohanty, PhD, President and Cofounder; and Sulagna Bhattacharya, CEO and Cofounder of Nanoscope TherapeuticsOptigo is developing binders intended to extend the duration of top-performing intravitreal drugs without compromising efficacy. The company has already had promising results in clinical trials with aflibercept. What’s next?Revive Biotech focuses on central retinal artery occlusion. Its products work by injecting oxygen-loaded nanobubbles into the eye intravitreally. Preclinical studies have advanced through proof of concept. Nanobubbles?Dr. Singer is a principal investigator in Unity Biotechnology’s clinical trial for UBX-1325, a therapeutic in development to treat diabetic macular edema and wet AMD. If approved, the product could work as an adjunct to anti-VEGF therapies.Nanoscope Therapeutics is developing gene therapies that focus on ambient light-sensitive molecules to treat inherited and acquired retinal diseases. Its lead product, MCO-010, is moving through Phase II trials. Why ambient light?Tune in to hear today’s experts discuss:How Optigo plans to extend the duration of afliberceptThe impact of extending duration activity on patients, physicians, and payersWhat Optigo plans to accomplish over the next 12 monthsWhat’s behind Revive Biotech’s proprietary technology and what makes it unique.The milestones it has completed so far with relation to clinical trials, intellectual property, and fundingThe new class of therapeutics being developed by Unity BiotechnologyThe data released so far on the UBX-1325 BEHOLD trialIf approved, the impact of UBX-1325—an agent that may potentially extend the life of anti-VEGF therapies—on clinical practiceThe potential impact of Nanoscope Therapeutics’s MCO-010 on patient communitiesThe feedback reported from clinical trial participantsThe critical milestones Nanoscope Therapeutics intends to achieve over the next year[Listen Now]

OIS Podcast host Carey Powers speaks with four CEOs from leading retina-focus companies to talk about all things innovation. Her guests include:•  Kerrie Brady, BPharm, President and CEO of OcuTerra•  Rich Small, CEO of NeuroTech Pharmaceuticals•  Kester Nahen, PhD, CEO of Notal Vision•  Brad Doerschuk, President and CEO of InFocus ClinicalOcuTerra is developing OTT166, a novel small molecule designed to treat diabetic retinopathy.The product is getting attention because it can deliver product to the retina via an eye drop application, said Kerrie Brady, BPharm, CEO of OcuTerra.The company has completed enrollment for a Phase II trial in 225 patients with diabetic retinopathy. They hope to have topline results in early 2024.Next up: Rich Small, CEO of NeuroTech Pharmaceuticals. The company’s Encapsulated Cell Therapy (ECT) technology enables continuous production of therapeutic proteins to the eye.ECT is central to NT-501, a product being developed to treat macular telangiectasia (MacTel) as well as glaucoma.Third in line: Kester Nahen, PhD, CEO of Notal Vision. Notal Vision provides remote patient monitoring services for patients with retinal diseases. Its teleconnected devices use AI and analytics to give physicians insight into retinal activity in between patient visits. The company is also developing a home OCT device that has received Breakthrough Device designation from the FDA.Brad Doerschuk, CEO of InFocus Clinical, closes out the podcast by discussing the value of contracting with a specialist. He says InFocus is the first and only retina specialty CRO. The depth of ophthalmology expertise at the organization is hard to find, he says, and it enables the company to offer comprehensive, high-touch services to its clients.Other topics covered on today’s episode include:•  The mechanism of action of OcuTerra’s OTT166•  The opportunities that arise from a noninvasive local therapy and how this type of therapy could transform the standard of care.•  How NeuroTech’s ECT platform delivers proteins to the back of the eye.•  Details on NT-501’s Phase II and III studies.•  What 10 years of real-world data revealed about patients that use Notal Vision’s ForeseeHome.•  How Notal Vision’s Home OCT is helping clinical trial investigators.•  How Home OCT aids long-term treatment.•  What sets InFocus Clinical apart from other CROs that run ophthalmology studies.•  The latest additions to InFocus Clinical’s partnership program[Listen Now]ResourcesOcuTerra Therapeutics           ocuterratx.comNeuroTech                              neurotechpharmaceuticals.comNotal Vision                            notalvision.comInFocus Clinical                       infocusclinical.comCarey Powers:                          ois.net/carey-powersFor more on at-home OCT, give Episode #377 with Anat Loewenstein, MD, a listen. https://ois.net/the-latest-on-at-home-oct-with-anat-loewenstein-md

At-home OCT enables daily monitoring of patients with neovasular age-related macular degeneration (AMD) and other patients that need a lot of follow-ups.With host Carey Powers, Dr. Anat Loewenstein dives into at-home OCT innovation, application, and adoption.Dr. Loewenstein is Head of the Department of Ophthalmology and Vice Dean at Tel Aviv Medical Center. She’s also a fellowship-trained vitreoretinal surgeon and has been heavily involved in research related to early AMD detection.Why all the fuss about at-home OCT? An at-home monitoring solution will potentially lessen the number of appointments for patients who don’t need them. More-frequent monitoring could also help catch disease changes sooner so doctors can facilitate treatment asap.Listen to the podcast today to discover:How at-home OCT works and the role artificial intelligence (AI) plays in image analysis.The patient experience when using at-home OCT.How disease activity alerts are delivered from the at-home device to the physician.Once a physician receives an alert, steps to take to get the patient into the clinic right away.The status of products closest to FDA approval, such as Notal Home OCT from Notal Vision.Dr. Loewenstein’s thoughts on the global health implications of at-home OCT.[Listen Now]ResourcesAnat Loewenstein: linkedin.com/in/anat-loewenstein-b48a595Carey Powers: ois.net/carey-powers

Keith Valentine is the first and only visually impaired head of a national sight loss organization in the UK.As the President and CEO of Vision Foundation, London’s leading sight loss charity, Valentine guides an organization that provides services for blind and visually impaired people countrywide. He also has plans to increase the organization’s research commitment.In March 2023, Vision Foundation merged with Fight for Sight, the leading UK charity dedicated to stopping sight loss through pioneering research. Combined with Vision Foundation’s legacy as a service provider, the new organization intends to make a bigger impact on both science and services.Valentine said out of all the sight loss funding currently available in the UK, the majority goes toward much-needed services. Only a small slice is available for research. Vision Foundation currently distributes about £2 million per year to fund research, and it’s one of the larger UK sight loss charities.Valentine told host Rob Rothman, MD, the deficit of research funding “will be felt by the investor community and the scientific community. It will affect the sustainability of science in the UK and the ability to attract people to ophthalmology as a profession.”Valentine intends to use what he learned in both the private and non-profit sectors to avert that deficit.Listen to the podcast today to discover:More about Valentine’s background, including his transition from the private sector to nonprofit sight loss, and how his experience with retinitis pigmentosa influenced his career path.The structure and scope of the charitable sight loss sector in the UK, including its approach to funding.How Valentine’s experience as a start-up founder influences his role leading a nonprofit.How Valentine plans to accelerate Vision Foundation’s scientific investment.His thoughts on whether nonprofits could or should benefit financially from their scientific investments and what that would look like.The potential and risks involved for nonprofits that invest alongside venture capital firms to advance innovation.[Listen Now]ResourcesVision Foundation                   visionfoundation.org.ukKeith Valentine:                       linkedin.com/in/keith-valentine-70281635Robert Rothman, MD:            ois.net/robert-rothman-md

Two recent drug approvals changed the game for ocular surface disease: Xdemvy (lotilaner ophthalmic solution) 0.25 percent (Tarsus Pharmaceuticals) for Demodex blepharitis, and Miebo (perfluorohexyloctane ophthalmic solution) from Bausch + Lomb and Novaliq for evaporative dry eye disease. On today’s podcast, two ocular surface disease experts talk about these and other developments related to dry eye.Our guests:Laura Periman, MD, aka “the dry eye master” and founder of Periman Eye InstituteLisa Nijm, MD, JD, a corneal, cataract, and Lasik specialist at Warrenville Eyecare and Lasik in Warrenville, IllinoisDr. Periman was an investigator in the Xdemvy clinical trials, and Dr. Nijm was involved in an extended observational study.“Before Xdemvy, patients’ options were limited,” Dr. Nijm told host Carey Powers. “When treated with Xdemvy, at one year, about 60 percent of patients still had clearance of Demodex.”Periman noted that during clinical trials, within a week or two she noticed “impressive improvements” in redness, reduction of collarette, and mite load in patients treated with Xdemvy. She also said the drug was “extremely well tolerated.”Miebo, a product designed to prevent excessive tear evaporation in patients with dry eye, is also expected to bring relief to a wide number of people. Dr. Periman sees Miebo as a “rapid go-to” for patients with an evaporative component, as it will potentially allow the ocular surface to protect the cornea as it’s supposed to.These two products alone will help make ocular surface diseases easier to manage; however, other exciting innovations emerging later this year could liven up the playing field.Listen to the podcast today to discover:Drs. Periman and Nijm’s insights into the Xdemvy clinical trias and why they’re not surprised the drug received early FDA approval.How to identify Demodex in the clinic: a quick tip from Dr. Periman.Why patient education around lid hygiene remains important even with use of Xdemvy.How to best use the latest dry eye treatments to treat ocular surface disease.What makes Miebo a unique and widely applicable product.Innovations on the horizon in dry eye disease, from pharmaceuticals to neurostimulators.How the aesthetic components of dry eye disease factor into clinical care.[Listen Now]ResourcesLisa Nijm, MD, JD: warrenvilleeyecare.comLaura Periman, MD:  dryeyemaster.com/about-laura-perimanCarey Powers: ois.net/carey-powers

Yari Mitchell spent nearly 13 years with AcuFocus, an ophthalmic device company, before overseeing its acquisition by Bausch + Lomb. As head of Y Factor Consulting, she now helps innovators move their product from the lab to a funded company.Greg Kunst, President and CEO of Aurion Biotech, a cell therapy company, led the start-up to a $120 million raise in 2022.Both Mitchell and Kunst sat down with host Carey Powers to discuss two topics they’re more than familiar with: raising capital and navigating M&As.When you’re working to raise funding, a gift for storytelling will take you far, they said. That story must show how your product will take market share or otherwise deliver value. The story must be unique enough to spark interest, but not so unique that it scares off investors.“You need to have a clear unmet need and you have to be different,” said Kunst.Start-up founders must also consider reimbursement paths as early in the process as feasible.Mitchell and Kunst also advised listeners on how to stand out when you have a limited budget. Hint: an organized pitch deck trumps a flashy but disjointed presentation.Navigating topics ranging from product differentiation to pitching complex scientific ideas to running out of money, both Mitchell and Kunst came back to a quote commonly attributed to Zig Ziglar:“It’s never as good or as bad as you think it is.”Listen to the podcast today to discover:Start-ups solve scientific problems in many ways. Does that approach make it easier or more difficult to sell to investors?The areas that are most critical to invest when you want to differentiate yourself from the competition—without blowing the budget.The importance of physician voices when building a brand.How Mitchell and Kunst overcame some of the biggest obstacles in their paths.Advice to stay financially and emotionally stable while building a start-up.The importance of disconnecting.Their thoughts on ChatGPT and its impact on patient education.[Listen Now]ResourcesYari Mitchell: linkedin.com/in/yarimitchellGreg Kunst: linkedin.com/in/greg-kunst-16647a1Y Factor Consulting: linkedin.com/company/y-factor-consulting-incCarey Powers:  https://ois.net/carey-powers

Wesley Jackson, PhD, spent years conducting post-doctoral research and writing grants, all the while setting the wheels in motion to launch Valitor.Valitor is developing VLTR-557 a long-lasting anti-VEGF. The technology platform, a multivalent polymer (MVP), is integral to VLTR-557.With Firas Rahhal, MD, Dr. Jackson shares why he stuck with the science behind Valitor during his PhD studies and beyond. He also discusses why he kept his sights set on entrepreneurship while his colleagues pursued academic careers.Long story short: Dr. Jackson worked for a medtech start-up as a college student and fell for the “we’re all in this together” culture of the company.As the scientist behind MVP, Dr. Jackson says his commitment and passion for the company and its products give Valitor a competitive edge. A larger company may shelve an acquired product, leaving it to sit ignored. The start-up has ownership, and will maintain that responsibility for as long as it takes.Listen to the podcast today to discover:More about Dr. Jackson’s background, which includes a PhD through a joint Bioengineering program at UCSF and UC Berkeley, followed by post-doc research at NIH.Details on spinning up Valitor: tech transfer, intellectual property challenges, securing funding. How it all came together and the people that helped make it possible.The right time to move forward with a spinout as an academic. Is it when you raise institutional money? When you assemble a team? Or something else?The science behind Valitor’s multivalent biopolymer technology: how it was conceived, how it works, and the molecules it works with.How Valitor’s technology addresses wet AMD and why the company calls their lead product, VLTR-557, the second-generation anti-VEGF.How the technology uses hyaluronic acid to develop a long-lasting product.The current state of Valitor, both scientifically and as a business.[Listen Now]ResourcesWesley Jackson, PhD: linkedin.com/in/wesleymjacksonFiras Rahhal, MD: ois.net/firas-m-rahhal-mdValitor: valitorbio.com

Aziz Mottiwala, Chief Commercial Officer of Tarsus Pharmaceuticals, says the company looks for honest unmet needs when deciding what targets to explore. It also looks for opportunities to be the first or the best.The company may meet both objectives with TP-03, an antiparasitic agent developed to treat Demodex blepharitis, among other conditions.Mottiwala describes lotilaner, the molecule behind TP-03 and other Tarsus therapies, as a “pipeline in a molecule.” The company is evaluating formulations of lotilaner for the treatment of Lyme disease and rosacea as well as Demodex blepharitis.With podcast host Carey Powers, Mottiwala and Bill Link, PhD, Managing Director of Versant Ventures and leader of the firm’s ophthalmology venture category, discuss how to execute successful direct-to-consumer campaigns, including the “eyelid check” campaign for Demodex blepharitis.They also discuss the investment outlook for eye care. With funding harder to come by, start-ups may want to take note of how Dr. Link evaluates companies, which he discusses in this episode. Hint: strong science and a solid business plan are not enough.Listen to the podcast today to discover:The five categories Dr. Link uses to evaluate an eye care company.Whether AI-based technologies are an attractive investment.How Tarsus evaluates opportunities in the pipeline.The Tarsus approach to DTC for TP-03 and why patients aren’t the initial focus.How 2023 is shaping up for investment and access to capital.Innovation Mottiwala is excited about and how Tarsus may integrate new technology into their commercial activities.How technology is impacting how Tarsus builds its organization.[Listen Now]ResourcesDemodex blepharitis campaign: https://eyelidcheck.comBill Link: https://www.versantventures.com/team/bill-link-phdAziz Mottiwala: https://www.linkedin.com/in/azizmottiwalaCarey Powers:  https://ois.net/carey-powers

Daniela Ferrara, Principal Medical Director at Genentech, calls her extensive medical training in Brazil her “north star.” Yet, she was frustrated by the limitations of clinical practice. “Having patients go blind under my watch, I realized I would never defeat blindness through practice,” she said.She turned her attention to clinical research, where her work could potentially improve the health of many rather than the few. More recently, with a focus on applying artificial intelligence and machine learning to multimodal imaging, her work could impact an even broader population sooner.With podcast host Firas Rahhal, MD, Dr. Ferrara discusses her medical experience in Brazil and her research fellowship at the Manhattan Eye, Ear & Throat Hospital, which is affiliated with New York University. She also discusses her move into industry; however, it’s not a complete switch: she maintains an academic affiliation with Tufts University School of Medicine, which allows her to stay connected to academia.Whether academic research or drug development, research simply takes too long and costs too much. AI presents a solution because of its ability to analyze massive amounts of data faster than most humans—without fatigue and without coffee breaks.Drs. Ferrara and Rahhal discuss that potential, as well as everyday use cases for AI. They also discuss Genentech’s current endeavors in AI and ophthalmology, which includes using AI modeling to predict retinal disease progression.Listen to the podcast today to discover:More on Dr. Ferrara’s professional background, including her medical training at Federal University of Rio de Janeiro in Brazil—one of the most prestigious universities in South America.How Dr. Ferrara’ work at Genentech has evolved from drug development to artificial intelligence in retinal imaging.How she defines AI and machine learning and why ophthalmology is an ideal focus area.The retina sub-specialties most amenable to near and/or long-term AI adoption.Details on Genentech research related to retinal condition diagnosis and treatment. Recent presentations include new studies on the use of AI and machine learning to predict geographic atrophy progression; and to assess wet AMD and DME disease activity faster and more accurately.How AI is already assisting physicians with real-time, in-the-clinic decision making, and what’s on the horizon.How AI can help accelerate drug discovery and development and why it’s imperative.How Genentech is working both in house and with external partners to develop AI-enabled tools.[Press Play]Resources:Daniela Ferrara, MD, PhD       https://www.asrs.org/find-a-specialist/profile/5348/Daniela-FerraraFiras Rahhal, MD                     https://ois.net/firas-m-rahhal-mdGenentech Ophthalmology    https://www.ophthalmologyvision.com

Host Carey Powers caught up with two digital health experts right after the Digital Ophthalmic Society (DOS) Digital Day program at the recent ASCRS conference in San Diego, California: Ranya Habash, MD, cofounder of MetaMed, DOS board member, and CEO of LifeLong Vision SPAC; and David Rhew, Global Chief Medical Officer and Vice President of Healthcare at Microsoft.On today’s podcast, the two thought leaders gave a quick recap of Digital Day before diving into how physicians can actually use digital tools in the “real world.”Dr. Habash and Rhew first discussed the promise of augmented and virtual reality and the metaverse, clearing up a common misconception: you don’t need a fancy headset to experience immersive technology.During MetaMed’s first-ever live-streamed 3D surgery in the metaverse, for example, doctors joined from their laptops and smartphones. That they could illustrates the potential to democratize advanced technology.Later, the conversation flowed to workflows. For ophthalmologists to use these tools consistently, they must be workflow compatible, Rhew said. They must save time, not add time.One use case: imagine if an AI-based tool could analyze images and automatically move abnormal screenings to the top of the inbox. How much time would that save?New technology can also save patients time, while allowing more of them to get access to necessary screenings. Healthcare practices saw this with telehealth during the pandemic. How else can we leverage technology to bring quality care to more people?Listen to the podcast today to hear our experts address the following:What innovations are the ophthalmology community most excited about?What were some of the top concerns raised about ophthalmic technology?What was it like to experience the first live-streamed surgery in the metaverse?How can surgeons leverage this type of technology?What are the barriers holding back many ophthalmologists from benefitting from new technology?How do physicians get started using generative AI and other new technologies?What makes ophthalmology an idea therapeutic area for exploring new technology?How can digital technology help improve health equity? How can digital technology help improve clinical trial recruitment and enrollment?[Press Play]ResourcesRanya Habash, MD https://med.stanford.edu/ophthalmology/education/ophthalmic_innovation_program/ranya-habash.htmlDavid Rhew     https://www.linkedin.com/in/david-rhew-m-d-1832764/Carey Powers  https://ois.net/carey-powers/The first live-streamed 3D surgery in the metaverse: https://www.youtube.com/watch?v=2ILJ7U8jbME

Innovation happens in labs, workshops, and garages worldwide. How does it happen in a global enterprise like Johnson & Johnson?Christoph Vonwiller, President of the Asia Pacific Region for Johnson & Johnson Vision, sheds light on that topic during a conversation with host Sophia Pathai, MD, PhD.As he sees it, start-ups and academic researchers stay laser-focused on solving a specific problem. They’re agile. They fail and succeed fast.A large, innovation-focused organization like J&J brings complimentary traits: muscle and legacy. “You can only be around for over 130 years if you’re continually innovating and evolving,” Vonwiller said.Start-ups bring the ideas, the science, and the passion. J&J contributes the resouorces to facilitate clinical trials, regulatory submissions, and commercialization strategies. It’s a balance of fast and methodical, lean and hefty.In Singapore, where Vonwiller leads his Asia Pacific team, J&J Vision recently launched the ELITA Femtosecond Laser, a next-generation vision correction system equipped for both flap lifts and lenticule extraction. Last year, the company teamed with Singapore’s Agency for Science, Technology and Research to establish an Eye Health Digital Innovation Consortium.Moving forward, Vonwiller sees his team taking the lead in the development of myopia treatment and management solutions. The company’s heritage in intraocular lenses and its continual innovation in that space will be of particular value for patients in Asia, as well.Listen to the podcast today to discover:A look into Vonwiller’s background and how he found his way to Singapore and J&J Vision.How Vonwiller’s experience in metabolism, R&D and business development inform his leadership career in ophthalmology.Key challenges and opportunities he faces when presenting an eye health agenda within a company with multiple therapeutic area focuses.How the businesses within J&J work together to help improve patient health.An Asia Pacific Region update: J&J’s partnerships, events and other activities and how they fit within Singapore’s ecosystem.Vonwiller’s leadership style: how he fosters a culture of collaboration and a desire to innovate, and how diversity and inclusion is part of that business imperative.What’s ahead for J&J at the affiliate level, and how the various regions help drive innovation forward.[Press Play]ResourcesJohnson & Johnson Vision     https://www.jjvision.com/Christoph Vonwiller                https://www.linkedin.com/in/christoph-vonwiller-66418a6b/Sophia Pathai, MD, PhD          https://ois.net/sophia-pathai-md-phd-mph/

Brian Culley, CEO of Lineage Cell Therapeutics, describes his company’s approach as “replace and restore.”In certain settings, replacing whole cells may provide restorative benefits that go beyond small molecule drugs, or even anti-VEGF therapies.Replacing dysfunctional or lost cell types with manufactured cells of the same type can restore activity. That means a potential reversal of disease progression rather than a slower road to vision loss.Lineage has taken this approach to develop a treatment for dry AMD. OpRegen is in a Phase IIa clinical trial to evaluate the cell therapy in patients with geographic atrophy secondary to AMD. OpRegen replaces the layer of damaged retinal pigment epithelium (RPE) cells with manufactured RPE cells via a single, 30-minute procedure.With host Rob Rothman, MD, Culley shares Lineage’s two-step allogenic cell production process and how the company applies it to ophthalmology. They also discuss how this process got the attention of Roche and other strategic partners—a rare win for a cell therapy company.Listen to the podcast today to discover:More about Culley’s background, which includes several years in molecular, cellular, and developmental biology, as well as technology licensing and business. That diversity in experience helps him evaluate Lineage’s path forward from multiple perspectives.The details behind Lineage’s approach: how it arrives at indication-specific stem cells and how its process differs from stem cell therapy.Why therapies that use undifferentiated stem cells deliver mixed results, but as the first step in a process, pluripotent stem cell lines have benefits.Why Lineage’s approach to cell therapy is especially useful for dry AMD, which is characterized by a loss in RPE cellsBrian’s thoughts on how the FDA approval of Syfovre (Apellis Pharmaceuticals) resets the bar for emerging dry AMD therapies.How the partnership between Lineage Therapeutics and Roche came to be and what makes both parties ideal partners.[Press Play]ResourcesLineage Cell Therapeutics      https://lineagecell.com/OpRegen                                 https://lineagecell.com/products-pipeline/opregen/Rob Rothman, MD                  https://ois.net/robert-rothman-md/

For today’s episode, the newest addition to the OIS Podcast team, Carey Powers, sits down with the newest additions to the Staar Surgical team: Warren Foust, Chief Operating Officer; and Magda Michna, PhD, Chief Clinical, Regulatory, and Medical Affairs Officer.Starr has led the way in implantable lenses for over 40 years, but like many medical device companies, not many patients have heard of them.That’s changing now that Staar has doubled down on direct-to-consumer advertising. To date, they’ve secured collaborations with the Jonas Brothers, Peyton List, and NBA player Max Strus, among others.Kudos from celebrities, as well as a 99.4% patient satisfaction rate, will help Staar emulate the company’s success in the Asia-Pacific region and Europe in the United States. A clinical strategy that includes physician partnerships will help those docs communicate the safety profile and benefits of Staar’s EVO-ICL lenses for myopia and astigmatism.Listen to the podcast today to discover:Starr Surgical’s approach to physician partnerships and patient education.Why Starr decided to integrate its clinical, regulatory, and medical affairs teams and Dr. Michna’s vision for all three.How Starr Surgical plans and executes its advertising and marketing campaigns, including influencer campaigns.Foust and Dr. Michna’s thought process behind making the move to Starr Surgical from Johnson & Johnson and AcuFocus, respectively.[Press Play]ResourcesStaar Surgical                          https://www.staar.com/Carey Powers                          https://ois.net/carey-powers/

Nataša Jovic has led marketing strategies for retina products since the launch of Visudyne. Approved by the FDA in 2002, Visudyne was the first commercially available therapy to treat wet AMD. Today, Jovic applies her scientific background and retina experience to lead marketing and commercial operations for RetinAI, a software company that supports R&D initiatives.As a retina specialist, OIS podcast host Firas Rahhal, MD, wanted to know: what’s the deal with AI? How can it help me in my practice? Jovic provides insight.At present, the FDA has approved over 500 AI-enabled medical devices, most of them in radiology and cardiology. Ophthalmology has seven. Those seven products, in addition to ancillary unregulated devices, she says, have the potential to streamline workflows, expedite clinical research, and generally assist in the clinical decision-making and care management.Listen to the podcast today to discover:More about Jovic’s background, which included managing Visudyne’s marketing strategy.AI 101: The difference between machine learning, deep learning, and AI and what each of these disciplines do.Why ophthalmology—and retina specifically—is an ideal therapeutic area for AI-based applications.The general regulatory pathways and considerations for AI-enabled medical devices and clinical decision support (CDS) software compared to traditional medical devices and CDS.The value of AI-based technology in streamlining intravitreal injection process and treatment decision-making.The direction for ophthalmology clinical trials, including the use of data to narrow inclusion criteria.Why AI will continue to play an integral role in drug discovery and development, and the benefits of that change.The details behind RetinAI’s Discovery Unity data management platform and Discovery Core for research analysis, including how they perform.[Press Play] ResourcesRetinAI                         https://www.retinai.com/Natasa Jovic                https://www.linkedin.com/in/natasa-jovic-b-sc-mba-8b40241/Firas Rahhal, MD         https://ois.net/firas-m-rahhal-md/Artificial Intelligence and Machine Learning-Enabled Medical Devices         https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

Cedric Francois, MD, PhD, is the cofounder, CEO, and president of Apellis, the company behind Syfovre, the first FDA-approved treatment for geographic atrophy.Like many, his path to the top of a successful publicly traded pharmaceutical company did not come fast or easy. He learned the hard way not to rely on “soft commitments” when funding a new venture. He also learned that good instincts and a better bottle of wine can go a long way toward persuading angel investors to open their checkbooks.In this conversation with Firas Rahal, MD, Dr. Francois details the long and winding path that led him from curious physician-scientist to pharmaceutical industry leader. He shares the story of how Syfovre came to be, as well as the hits and misses through 17 years of fundraising.Hits include turning around his first angel investor during an impromptu follow-up meeting. Misses include needing to raise money turning the Great Recession in 2009—a time when there wasn’t money to raise. He avoided bankruptcy by selling his company to Alcon later that year.He also shares how Eyetech/Pfizer’s Macugen—a trailblazer in anti-VEGF therapies—inspired the science behind what would later become Apellis. Listen to the podcast today to discover:More about Dr. Francois’s professional background, which took him from Belgium to Louisville, Kentucky, and from studying hand transplant surgery to developing retinal therapeutics.How Eyetech/Pfizer’s Macugen inspired Dr. Francois’s research into macrophages and complement inhibitors, which led him to develop products that target C3, the central protein of the complement cascade.What prompted a restart of the Phase III trial for Syfovre, the first FDA-approved treatment for geographic atrophy.The data behind how the drug’s efficacy amplifies between 12 and 24 months.For physicians: what it’s like to use Syfovre.How Apellis got its IPO done in November 2017, a process that included preparing S2 documents in two weeks and going on a four-day road show.How Dr. Francois secured his first angel investor, including the unconventional move that sealed the deal.His take on the potential diagnostics and other technology that could move retinal treatments forward.[Press Play]ResourcesCedric Francois, MD, PhD       https://apellis.com/people/cedric-francois-mdFiras Rahal, MD                       https://ois.net/firas-m-rahhal-mdApellis pipeline                       https://apellis.com/our-science/our-pipeline/

Jodbhir (Jod) Mehta, PhD, is the Head of the Tissue Engineering and Stem Cell Group at the Singapore Eye Research Institute and Head of the Corneal Service and Senior Consultant in the Refractive Service of the Singapore National Eye Center (SNEC).Dr. Mehta, a corneal and refractive surgery expert, has spent most of his career in Singapore, a small, thriving nation with one of the most successful healthcare systems in the world. But he trained in London and Birmingham, England.Dr. Mehta could have stayed in England and done quite well. Instead, he chose to continue his career in Singapore, a country where he could make an even deeper impact.He arrived, to a new country and a new culture, with $500, knowing no one. That was over 15 years ago.With podcast host Sophia Pathai, MD, PhD, Dr. Mehta shares why his unconventional path—to pursue a fellowship on a small island thousands of miles away—made all the difference.He also discusses his research into corneal transplantation, his early adoption of femtosecond lasers, and how his research has informed his clinical practice.Finally, he gives a glimpse into Singapore’s biotech industry, which he compares to Israel for its strong ecosystem of investors and innovators. It’s driven, he says, by a population with an inherent can-do attitude and a high bar for success.Listen to the podcast today to discover:Dr. Mehta’s background, from neurosurgery in London to ophthalmology in Singapore.The personal and professional challenges he faced upon relocating from London to Southeast Asia.His thoughts on the Singapore economy and biotech industry.His research in corneal disease, including clinical trials related to corneal disease treatments and publications related to corneal disease and refractive surgery.How Dr. Mehta passes on his techniques to the physicians of the future.His thoughts on the potential of the metaverse for training and teaching, as well as generative AI as a tool for both patients and physicians.Advice for physician trainees interested in a career in ophthalmology, and why it’s “the most exciting field, hands-down.”[Press Play]

When Barry Linder, MD, was an ophthalmologist with Kaiser Permanente, he saw a familiar pattern. Patients with dry eye disease usually had Meibomian gland dysfunction (MGD). They were advised to place a wet warm washcloth over the eyelids twice a day. They’d inevitably abandon the protocol after a few days.Thinking there had to be a better way, he developed the EyeGenie, a simple but effective eye mask that delivers continuous heat for up to 15 minutes.For patients with moderate to severe dry eye, he developed the Eye Lipid Mobilizer (ELM), a device so effective that podcast host Paul Karpecki, OD, says it has “the most potential of any in the field of in-office procedures.”Dr. Linder, who founded Eyedetec Medical to develop and commercialize these products, says ELM embodies the following characteristics:It’s convenient (Patients can use it on their own after one in-office visit.)It’s affordableIt’s effectiveELM combines vibration, heat, and neuromodulation to decrease tear evaporation and to induce expression of oil from the meibomian glands. Bluetooth connectivity enables remote therapeutic monitoring.ELM is designed to be used in tandem with eye drops and other treatments. Dr. Linder says Eyedetec is currently preparing its FDA 510(K) submission and hopes to receive clearance by the end of this year.Listen to the podcast today to discover:Why Dr. Linder became an ophthalmologist and how his career evolved from clinical practice to entrepreneurship.Advice for ophthalmologists who want to transition into founding and leading a company.The key ingredients that enabled Dr. Linder to move from idea to FDA-cleared product.His approach to business, which runs contrary to the “fail fast” model common among start-ups.How the Eye Lipid Mobilizer induces liquefaction, mobilization, and expression in patient with moderate to severe dry eye disease.[Press Play]

If ophthalmology clinical trials were burgers, mitomycin would be the mustard at the table of every U.S. restaurant with a burger on the menu.*Using this analogy, Mitsol, developed and manufactured by Mobius Therapeutics, is the only FDA-approved mitomycin-c “mustard” formulation with an ophthalmic indication.In reality, the mitomycin story in ophthalmology is more complicated than that, says Ed Timm, Founder, Chairman, and CEO of Mobius Therapeutics.Mitomycin-c is used by ophthalmologists to prevent scarring during surgery. Before the FDA approved Mitosol, surgeons would have to obtain a formulation of the antimetabolite from a compounding pharmacy. Because of its instability, the effectiveness of off-label use could vary.All that changed with the arrival of Mitosol, which is a standardized product that requires no refrigeration, no light-shielding, and has a 24-month shelf life.Unfortunately, ophthalmologists still have to develop off-label formulations of other products for use during surgery, which leads to unpredictable outcomes.Mobius is doing its part to change that.With podcast host Rob Rothman, MD, Timm discusses the benefits of using an assuredly sterile, assuredly potent product and Mobius’s plans to expand Mitosol’s use beyond glaucoma surgery, keratectomy and pterygium.*Burger-mustard analogy courtesy of Ed TimmListen to the podcast today to discover:The Mobius strategy to expand into other indications and specialties.Timm’s take on recent recalls of contaminated eye drops and what it means for development and manufacturing moving forward.Mobius’s plans for growth over the next few years, including potential strategic partnerships.Timm’s professional background, which took him from American Hospital Supply to building Synergetics (later sold to Bausch + Lomb) to Mobius Therapeutics.What Dr. Rothman sees as a recurring theme in ophthalmology and how it creates better leaders and investors.[Press Play]

In pharma, it takes many failures to achieve one breakthrough. Dompé, a family-owned global biopharmaceutical company, focuses on long-term success, knowing those wins impact thousands or even millions of patients.Gianluca Rossetti, Strategic Planning & Corporate Business Development Director at Dompé, was drawn by the company’s ambition, passion, and commitment to innovation and science.Today, he uses his management consulting background to guide the company’s business strategy, lead strategic projects, and provide direction as the company expands its ophthalmology portfolio.With podcast host and retina surgeon Firas Rahhal, MD, Gianluca shares Dompé’s vision and gives details into its pipeline. He also provides insight into what’s kept the company going for over 130 years—through two world wars and two pandemics.A clue: as a family-owned company, Dompé focuses less on quarterly results and more on long-term impact.Listen to the podcast today to discover:Gianluca’s professional background: why he chose to start in management consulting and what brought him to pharma, and most recently, what brought him to Dompé.Dompé’s criteria for drug discovery and development.The pros and cons of running a family-owned pharmaceutical company vs a large publicly-owned corporation.How Oxervate (cenegermin-bkbj), the first FDA-approved treatment for neurotrophic keratitis (NK), has performed over the past five years.What else is Dompé has planned for NGF products, including front- and back-of-the-eye indications.Dompé’s plans to expand its presence in ophthalmology.Details into the Exscalate program – its platform that applies artificial intelligence to drug discovery ophthalmic innovation.[Press Play]

Dompé, a family-owned global biopharmaceutical company with roots that date back over 150 years, built its legacy by following two principles: take calculated risks, and focus on need rather than precedent.Georgea Pasedis, PharmD, RPh, Dompé’s Senior Vice President and Global Head of Medical Affairs, moved into her current role by following similar principles. After earning her PharmD and practicing at the renowned Mass Eye and Ear in Boston, Dr. Psedis determined she could make a broader impact by transitioning to industry.In her medical affairs role, Dr. Pasedis discusses the science behind Dompé’s products with physicians worldwide. That education includes intel on rhNGF (recombinant human Nerve Growth Factor), the protein that forms the basis for Oxervate (cenegermin-bkbj) the first FDA-approved treatment for neurotrophic keratitis (NK).With podcast host Paul Karpecki, OD, FAAO, Dr. Pasedis discusses the mechanism of action behind Oxervate and how it helps both early- and late-stage NK patients.She also discusses how Dompé has remained a successful family-owned business for multiple generations. Its U.S. subsidiary, launched in 2018 in record time, serves as an example of Dompé’s approach to science, to education, and to improving eye health for patients worldwide.Listen to the podcast today to discover:How Dr. Pasedis’ nonlinear career path led her to Dompé.How Dompé harnesses innovation differently as a family-owned business.How Dompe built out its U.S. launch in only three months.Why physician education is so important when it comes to diagnosing and treating NK.Dompe’s long-term plan for Oxervate, including in both early- and late-stage NK patients.Advice for other professionals considering a transition from the clinic to industry.[Press Play]

As Vice President and General Manager of U.S. Surgical for Bausch + Lomb, Anthony Wallace is involved in virtually all things surgical. His day-to-day includes strategy, portfolio planning, R&D alignment, acquisitions, pricing and contracting, sales and marketing, and supply chain.On top of all that, he’s one of the key executives leading Bausch + Lomb’s five-year charge: double the number of patients reached from 2 million to 4 million.During a candid discussion with podcast host and retina surgeon Firas Rahhal, MD, Wallace discusses how current healthcare policy will affect surgical device and drug development, pricing, and patient outcomes.He also shares stories from his tenure at Novartis, including the dark time when the company called off three Beovu clinical trials due to cases of occlusive vasculitis. “It was the fastest I’ve seen any company move and it was in the name of patient safety,” he said.Listen to the podcast today to discover:The feedback Bausch + Lomb has received on Stellaris Elite for both cataract and retina procedures and how the company plans to improve on the device.Details on the Bi-Blade vitrectomy cutter and the significant upgrade Bausch + Lomb is currently testing.How Wallace identifies gap areas in surgical tools to build out the Bausch + Lomb pipeline.More details on what Wallace’s job entails as VP and GM of U.S. Surgical for Bausch.Lessons learned from nearly a decade at Novartis.An update on Bausch + Lomb’s Synergetics acquisition from 2016 and the state of the relationship after seven years together.What’s makes the retina space unique compared to other therapeutic areas.How the Inflation Reduction Act impact drug and device development, short and long term.What’s ahead for ophthalmology innovation in the next three to five years.[Press Play]

Today’s podcast shines the spotlight on the front of the eye, focusing new treatments and approaches to dry eye disease, blepharitis, and Sjogren's Syndrome, to name a few.Kelly Nichols, OD, PhD, dean of the University of Alabama at Birmingham School of Optometry, guides a panel of four clinical and industry experts through a robust conversation on ocular surface disease.They start by sharing their optimism around new treatments and awareness initiatives. Jeffrey Nau, PhD, president of the newly formed Viatris Eye Care Division, said progress is inching along now, but “it’s only a matter of time until we have a massive uplift that will completely change the way we look at ocular surface disease.”In late 2021, the FDA approved Tyrvaya, the first nasal spray for dry eye disease. Researchers continue to evaluate treatments and diagnostics from multiple angles. Physicians continue to tailor their approaches to better educate, diagnose, and treat ocular surface disease patients. What’s next?Listen to the podcast today to hear the panelists discuss these and other topics, including:What excites you about current and emerging eye care innovations?What’s your approach for both new and returning dry eye patients?What’s your typical patient intake workflow?How much time do you spend educating dry eye patients?How important are companion diagnostics in ocular surface disease?[Press Play to Listen]

Myopia has escalated to epidemic proportions with a global prevalence twice that of obesity. A study published in JAMA Ophthalmology in 2021 found the prevalence of myopia in six-year-old children in China jumped from 5.7% between 2015 and 2019 to 21.5% in 2020. Given myopia affects about 40% of Americans and up to 90% of the East and Southeast Asians, it’s time to pick up the pace on education, treatment, and management. At OIS XII in San Diego, a panel of experts discussed how the eye care community can make a difference in myopia within the pediatric population. Moderated by David Kading, OD, of Specialty Eye in Seattle, Washington, the group discussed current FDA-approved and off-label treatments, as well as emerging solutions. They also discussed the importance of raising parent awareness to reduce risk and progression of this disease. Listen to the podcast today to hear the panelists discuss: ·         What’s happening now in the myopia management space.·         Is myopia a disease?·         Exciting myopia developments coming in the next two to three years·         Steps to improve parent and patient education around myopia·         What it will take to significantly accelerate myopia treatment development and commercialization in the next five years·         Promising investment opportunities in myopia over the next five years Speakers:Robert A. Clark, MD—South Bay Family Eye/Associate Clinical Professor of Ophthalmology, Stein Eye InstituteRajeev Garg, PhD—Global Head, Myopia Management Strategy, CooperVisionMatt Oerding—Board Member, GMAC/CEO & Co-Founder, Treehouse EyesDavid Kading, OD, FAAO, FCLSA—CEO, Specialty Eye (moderator) Hit “Play” to Listen.

Robert Avery, MD, CEO of California Retina Consultants, balances roles as physician and researcher with a lucrative additional career: advising life sciences companies and ophthalmology focused venture capital funds. With colleague and podcast host Firas Rahhal, MD, Dr. Avery talks about how he got into the business side of medicine. He also looks back over 30 years of retina, which includes pioneering the use of anti-VEGF agents for retinal disease.Looking forward, Dr. Avery shares his views on what’s on the horizon for drug delivery platforms. And for the drug and device developers in the audience, he discusses how to leverage scientific advisory boards to gain valuable, practical insight.Listen to the podcast today to discover:How Dr. Avery built his clinical research practice in Santa Barbara, California. It’s home to University of California Santa Barbara, a Tier 1 research university, but otherwise not a primary center for clinical trials.Tales from the early days of Avastin, including how Dr. Avery helped get the drug approved for off-label use to treat age-related macular degeneration. That it was approved for off-label use before Lucentis received FDA approval helped it become part of the standard of care.How Dr. Avery balances clinical practice with advisory roles and how these dual careers benefit one another.His prediction on emerging drug delivery platforms.What it takes to advise an investment group on drugs and devices as they relate to clinical practice. In other words, will doctors use this?Hit “Play” to Listen.

CooperVision’s Global Head of Myopia Management Strategy, Rajeev Garg, made a bold move over a decade ago. After a fruitful career in R&D for Abbott and Merck, he got his MBA and transitioned to the commercial side. It worked out well. He led global teams for Johnson & Johnson and Bausch + Lomb before joining one of the industry’s leading contact lens makers. With ophthalmologist and venture capitalist Ehsan Sadri, MD, Rajeev shares CooperVision’s path forward for myopia innovation. CooperVision’s MySight one-day contact lenses are the only FDA-approved contacts designed to slow the progression of myopia in children. CooperVision wants to build on that success by ramping up physician training and education as well as raising consumer awareness on the importance of slowing the progression of myopia. It’s taking the lead through joint ventures, acquisitions, and other partnerships. CooperVision also encourages physicians to take the Myopia Management Pledge. Are you ready to make myopia management part of your practice? Listen to the podcast today to discover: · How Rajeev’s experience in eye care has differed from other therapeutic areas. · Rajeev’s career milestones at Bausch + Lomb, Johnson & Johnson, and CooperVision, and how innovation ties them together. · Rajeev’s thoughts on how to address the myopia epidemic in Asia. · Details on CooperVision’s multimodal treatment strategy. · Where Rajeev sees CooperVision evolving over the next few years. · His advice for emerging leaders on how to move through career obstacles and transitions. Hit “Play” to Listen.

Elevated intraocular pressure (IOP) is the only modifiable risk factor for glaucoma. The more IOP data, the better physicians can evaluate treatment impact, which is critical to preserving vision.Implandata Ophthalmic Products GmbH developed the eyemate® technology platform to fill that need. The implantable sensor, powered and read by a hand-held device, allows physicians to monitor IOP between visits.Implandata CEO and cofounder, Max Ostermeier, discussed the technology and the gap it fills with glaucoma specialist and OIS podcast host Rob Rothman, MD. Better IOP monitoring, they argue, can help change the paradigm of patient care.Listen to the podcast today to discover:How the eyemate system works and how it may help glaucoma patients, including those with low-tension glaucoma.A deeper dive into eyemate study results, which includes 10 years of in vivo data.Implandata’s near-term plans for developing eyemate further, including miniaturizing the sensors and potentially combining it with other therapeutic devices.Implandata’s plans to bring the CE-marked eyemate system to the U.S. market.How Ostermeier made the transition from a finance executive to founding and leading medical device start-ups. Plus, the value of gained from his mentors.More on Ostermeier’s career and how it led to Implandata.

Applications of the metaverse go far beyond gaming and social media. In healthcare and life sciences, innovative physicians and researchers are exploring its potential to accomplish the following: Enhance decentralized clinical trialsDevelop precision medicine therapiesImprove surgical navigation e.g., to perfect a surgical route before treating the patientEnhance surgical education, training, and mentoringAs part of connected care and virtual careTo create medical storefronts Because ophthalmology is considered one of the most innovative fields in medicine, it’s no surprise physicians are discussing ways to use this alternate community to enhance clinical care. In this podcast, three ophthalmology thought leaders explore what’s possible for eye care in the metaverse. They discuss how digital twins can enable precision medicine. They discuss its application for visual field testing and its potential to identify disease earlier to enable proactive care. Listen to the podcast today to discover: What lies ahead for precision medicine?How will digital twin virtual models enable more tailored treatments? What’s possible? What’s already in the works?What is the benefit of the metaverse and digital twins on decentralized clinical trials?How are surgeons using augmented reality and virtual reality, as well as a new device called PillBot?How do we gauge clinical performance and metrics in the metaverse?If we can monitor patients in the metaverse, can we enhance or augment their capabilities in that reality?How will this technology help democratize medical education and medical care?How will the metaverse enable better collaboration and communication among physicians, clinicians, and researchers? Panelists:Michael F. Chiang, MD, Director, National Eye Institute, National Institutes of HealthPam Nesbitt, Global Chief Architect for Healthcare & Life Sciences, MicrosoftKhizer Khaderi, MD, MPH, Founder & Director, The Human Perception Lab at Stanford; Founder & CEO, VizzarioRanya Habash, MD, Co-Founder, MΞTAMΞD; FDA Digital Health Network of Experts; Medical Director, Technology Innovation, Bascom Palmer Eye Institute; Visionary Innovation Mentor, Stanford University

With extensive experience as both a medical and technology professional, Khizer Khaderi, MD, MPH, could be described as either a technology whiz who practices medicine or an ophthalmologist pursuing technology. In reality, he falls into a field all his own, combining what he knows about sports performance, vision, and advanced technology into a career that currently includes teaching, research, and leading an AI start-up (Vizzario).Dr. Khaderi is the clinical associate professor at the Bayers Eye Institute at Stanford University, founder and director of the Stanford Human Perception Laboratory and the Stanford Vision Performance Center, and faculty at the Stanford Institute for Human-Centered AI. In this week’s podcast, he speaks with host Sophia Pathai, MD, PhD about the potential for augmented reality, virtual reality, the metaverse, and Web3 in clinical care.But before all that, he talks about a career that started in his teens—he started medical school at 19 after earning his master’s in public health. During his residency in ophthalmology at the University of Arizona, his research focused on vision performance in athletes.Working with the school’s basketball team, which included soon-to-be-NBA-pro Dell Curry, he focused his research on how athletes perceive and what happens to their retinal ganglion cells as they do. His findings led him to launch a video game start-up centered on sports performance. When that didn’t take off, his path returned to ophthalmology. Listen to the podcast today to hear Drs. Pathai and Khaderi discuss:· How Dr. Khaderi started the Stanford Human Perception Laboratory and what he’s learning about virtual reality and visual perception.· The Vision Performance Index, a tool used to analyze vision-related data.· Exciting biomedical device developments on the horizon for 2023.· How Dr. Khaderi sees technology and medicine evolving – together – over the next few years.· His views on what the intersection of technology and medicine means for today’s residents and medical students.· What lies ahead for Web3 and the metaverse in clinical settings. How will they have an impact?Hit “Play” to Listen

Fuchs Endothelial Corneal Dystrophy (FECD), a progressive hereditary disease that causes blurred or cloudy vision and vision loss, has no cure other than transplant of endothelial layer.David Eveleth, PhD, founder, president, and CEO of Trefoil Therapeutics, wants to change that.The company’s lead product, TTHX1114, has the potential to medically treat FECD and other corneal dystrophies without transplant. If successful, they’ll give patients an alternative to surgery as well as improve access to treatment for people with corneal diseases worldwide.With podcast host Rob Rothman, MD, Dr. Eveleth discusses the science behind TTHX1114, which was designed to treat ulcerative conditions on the front surface of the cornea.Encouraging Phase II results showed TTHX1114 led to a dose-related reduction in corneal edema in Fuchs patients who underwent a Descemet Stripping Only procedure. The drop could potentially help some patients avoid transplant and reduce edema secondary to cataract surgery, Dr. Eveleth said. Listen to the podcast for the full story. You’ll discover:·         How Trefoil came to fruition and why it focuses on Fuchs Endothelial Corneal Dystrophy and other corneal diseases.·         What Dr. Eveleth said during his meeting with Dr. Rothman’s VC firm, InFocus Capital Partners, that convinced them to move forward.·         Details on the Phase II study for TTHX1114, which explored the drug’s use in patients with Fuchs undergoing a Descemet Stripping Only procedure.·         Why Trefoil’s mission is a global health issue.·         More about Dr. Eveleth’s background and why he chose biotech over academia. [Listen Now]

Podcast Description: More than 300 clinical thought leaders, pharma industry executives, and ophthalmology investors gathered recently in San Diego, CA, for OIS XII. In addition to announcing pivotal new data, presenters discussed drug and device innovations, advances in clinical trials, and how to gain or maintain a competitive edge in today’s market.For this week’s OIS Podcast, surgeon Ehsan Sadri, MD, co-founder of Visionary Ventures; and Sharon Bakalash, MD, PhD, founder and CEO of SB Strategic Development Consultants, sat down with an all-star cast of ophthalmology leaders. Here’s a preview of the cast and what they talk about:·         Avellino CEO John Robson, on how he brings decades of experience analyzing data to eye care. He also explains how (and why) Avellino uses artificial intelligence and machine learning to fuel drug discovery—specifically, precision medicine therapies.·         Dompé’s global head of medical and clinical affairs Georgea Pasedis, PharmD, gives an update on Dompé’s neurotrophic keratitis product. She also talks about how the company uses the fourth-fastest supercomputer in the world.·         Tyler Stowater, partner and vice president of Bluestem, a private equity company based in Sioux Falls, SD, shares how the company mitigates losses in a down market, as well as his predictions for the next few months.·         Iveric Bio president Pravin Dugel, MD, talks about Iveric’s Breakthrough Therapy designation for Zimura (avacincaptad pegol), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy.·         Mina Sooch, cofounder and CEO of Ocuphire Pharma, gives the scoop behind Ocuphire’s exclusive license agreement with FamyGen Life Sciences and what it means for the eye care sector at large.·         Ranya Habash, MD, cofounder of MetaMed, takes Dr. Bakalash on a tour of the metaverse.The podcast also includes insights from Tarsier Pharma founder and CEO Daphne Haim-Langford, PhD, and Stuart Therapeutics president and CEO Eric Schlumpf.Click “play” to listen.

Identifying MDs and ODs is but one of many activities involved in developing a commercial launch strategy. To execute that launch according to targets requires strong data, effective messaging, thoughtful strategy, and luck. According to a ZS analysis, out of 30 emerging pharma first launches from 2019 through 2021, only four met expectations.At the OIS XII panel “Maximizing OD/MD Market Potential and How to Achieve Commercial Success With a New Product,”a group of commercialization experts discussed what it takes to get a product to market and meet analysts’ expectations. Robert J. Dempsey, MBA, CEO and president of AsclepiX Therapeutics, moderated the panel. Tarsus Pharmaceuticals, for example, is launching TP-03, which would be the first approved treatment for Demodex blepharitis, a disease of Demodex mites infesting the eyelids. It affects about 25 million people. Tarsus Chief Commercial Officer Aziz Mottiwala said education and thoughtful patient identification are key elements of Tarsus’ strategy.  Education also plays a role when meeting with payers. Oyster Point Pharma president and CEO Jeffrey Nau, PhD, MMS, said ophthalmology companies must present a strong scientific story well before a product goes to market. Tony Tipton, COO of Xequel Bio, agreed, noting companies must also stay strong in their belief in the product and its value. Listen to the podcast today to hear this  expert panel discuss:How they approach conversations among payers, pharmacy benefit managers, and MDs and ODs.How key opinion leader relationships have shifted over the past 10 years.Precommercial strategies for a new company with a new launch.Strategies for navigating the payer space.Obstacles and opportunities in pre-launch. Key performance indicators for measuring the early success of a commercial launch.Also participating on the panel was Carey Powers, global head of corporate marketing, Avellino Lab USA.Click “play” to listen.

For more than 30 years, Heidelberg Engineering has set the standard in diagnostic imaging. Best known for imaging quality and optical coherence tomography (OCT) capabilities, Heidelberg focuses on innovation, customer service, and education. OIS Podcast host Sophia Pathai, MD, PhD, caught up with Heidelberg’s VP/head of corporate strategy Kfir Azoulay, as well as Heidelberg Engineering UK managing director Tosh Vadhia. From their respective locations in Heidelberg, Germany, and London, the two discussed what’s behind Heidelberg Engineering’s success. Although the company retains the feel of a close-knit family business, it aims to move fast in response to technological advances. Its subsidiary, Munich Surgical Imaging GmbH, recently partnered with Bausch + Lomb to distribute its digital ophthalmic microscopy products globally. Together, the companies will create integrated solutions to meet the growing demand for digital surgical microscopy. Listen to the podcast to hear more about:The history of Heidelberg Engineering and what sets it apart.How Heidelberg Engineering ensures customers get the most out of its equipment.The scoop on the latest innovations at both Heidelberg Engineering and its Munich Surgical Imaging subsidiary, including digital microscopy.The challenges around market access and reimbursement with OCT and digital microscopy.How Heidelberg served its customers while navigating medical device reporting regulations and Brexit.The trends and opportunities in ophthalmology that Heidelberg Engineering is following, including OCT-based biomarkers and artificial intelligence.Advice for other emerging leaders interested in pursuing a career in the medical device industry. Click “play” to listen.

Scott Brun, MD, began his long career in pharma R&D leadership in the late 1990s, holding key roles at Abbott and AbbVie. Had he picked up a pencil with his right hand, his career may have taken a completely different turn.Dr. Brun earned his medical degree at Johns Hopkins University School of Medicine and completed a residency in ophthalmology at the Massachusetts Eye and Ear Infirmary. A leftie, Dr. Brun ultimately decided not to become ambidextrous. Instead, he joined Abbott as a pharmaceutical physician and began a fruitful career leading development across multiple therapeutic areas.With OIS Podcast host Sophia Pathai, MD, PhD, Dr. Brun looks both forward and ahead, sharing stories from his time at Abbott and AbbVie as well as his insights on promising developments in ophthalmology. At venture capital firm Abingworth, Dr. Brun currently helps young biopharma leaders turn their visions into reality. He’s also running his own consulting company and helping Horizon Therapeutics build its internal pipeline.Listen to the podcast today to hear Dr. Pathai and Dr. Brun talk about:Dr. Brun’s background, from medicine to industry to consulting and VC work. Pivotal events across therapeutic areas during his tenures at Abbott and AbbVie.  How Dr. Brun fostered teamwork, motivation, and engagement among large teams within large pharmaceutical companies, especially in times of failure. The differences between managing a team of six and leading an organization of 2,000 people across 40-plus countries.The success of Opthea and how it illustrates the need for VCs to think globally. How the current bear market will test early-stage biopharma and biotech, and how these startups can survive current economic challenges. The road ahead. What areas of development look most promising? Gene therapy for dry age-related macular degeneration? Ganglion cell regeneration? Something else?Click “play” to listen.

What if legendary ophthalmologist Don Gass, MD, had access to both optical coherence tomography (OCT) and artificial intelligence? One can only imagine the breakthroughs. Alex Walsh, MD, CEO of Envision Diagnostics and a retina specialist at Retina-Vitreous Associates in Los Angeles and vicinity, wants to bring Gassian interpretive capabilities to everyone in eye care.  His company’s product, a binocular OCT with the potential to image the entire eye, could enable physicians and technicians to get objective, comprehensive data in six minutes. No waiting, no moving from room to room. The device performs many of the functions of a routine eye exam, including slit lamp and dilated fundus exams, reducing the visit time from hours to minutes.  Dr. Walsh says the device brings clinical trial–level data to every exam, which is something eye-care professionals should be demanding. “We spend three times as much on labor as we do on devices, and we accept it as the cost of doing business,” he tells OIS podcast host, Retina-Vitreous Associates’ colleague and OIS Podcast host  Firas Rahhal, MD. “The linear model of a routine workflow is clearly inefficient.” Listen to the full podcast today to hear Dr. Walsh and Dr. Rahhal discuss how automation can transform the eye exam and how a binocular OCT can bring objective, quality data to eye-care professionals everywhere. Here’s what they cover: The advantages of an all-in-one diagnostic device for optometrists and ophthalmologists.The intellectual property and funding challenges that prompted Dr. Walsh to launch his product outside the academic environment.Early concepts of the Envision device and how it evolved into its current iteration.The proposed regulatory pathway for Envision’s OCT and what preliminary tests show.How lean manufacturing processes inform the Envision diagnostics philosophy.Whether entire-eye binocular OCT could influence a wave of new, more effective treatment options.The potential of automated diagnostics to improve the quality of data used for analysis, and what needs to change to make Big Data work for eye care.What’s next: AI as a diagnostic tool.Click “play” to listen.

The Food and Drug Administration approved Tyrvaya (varenicline solution), a multidose nasal spray, to treat signs and symptoms of dry eye disease, about a year ago. Jeffrey Nau, PhD, MMS, CEO of Oyster Point Pharma, sat down with OIS Podcast host Paul Karpecki, OD, FAAO, to discuss the launch and his learnings over the year that was.  Since then, about 62,000 Tyrvaya prescriptions have been written. It’s the first and only nasal spray designed for dry eye relief. Dr. Nau says refills and persistence numbers are strong.  Dr. Karpecki said he’s noticed similar results in his own practice. Of patients who received a Tyrvaya sample, the requests for prescriptions and refills have been dramatic. While Oyster Point has release positive post hoc data of Tyrvaya, Dr. Nau said there’s still a learning curve to overcome. Physicians simply aren’t used to prescribing a nasal spray for dry eye. Will that change in 2023? Listen to the podcast today to hear Dr. Nau and Dr. Karpecki discuss: How Oyster Point launched Tyrvaya after running Phase III trials at the peak of the pandemic.What Dr. Nau has learned from the Tyrvaya launch over the past year.The surprises that occurred during the Tyrvaya launch and how Oyster Point overcame them.How Oyster Point navigates uncontrollable events such as COVID-19 and the rocky economy.Oyster Point’s commercialization strategy for 2023—both for Tyrvaya and the rest of its pipeline. Click “play” to listen now.

For all the drugs, biologics, and medical devices approved for use in the United States and Europe, few of them make their way to China.AffaMed Therapeutics, a global clinical stage biotechnology company, was established to bridge the gap between global innovation and unmet need in China. With a focus on ophthalmology, neurology, and psychiatric disorders, AffaMed leaders want to serve the patients in China as well as support innovation.Podcast host Sophia Pathai, MD, PhD, caught up with AffaMed Chief Financial Officer Vijay Karwal to discuss the portfolio that will potentially enable AffaMed to fulfill its mission in ophthalmology.AffaMed’s pipeline includes products designed to address cataract and refractive surgery and retinal disease. One of those products is AM712, a fusion protein that inhibits VEGF and Ang-2. The company received clearance from the FDA on its Investigational New Drug application as well as China CTA clearance earlier this year.Karwal also talked about his role as partner at CBC Group, a globally recognized investment firm that supports the growth of healthcare companies in Asia. The firm’s borderless approach aims to leverage growth in Asia to build value in businesses worldwide.Listen to the podcast today to discover:The evolution of AffaMed within the biotech ecosystem in China.The strategy behind AffaMed’s ophthalmology portfolio.The unmet need for cataract surgery and intraocular lenses in China.The data behind AM712, a product designed to treat retinal vascular diseases.Karwal’s role at CBC Group, Asia’s principal healthcare specialist investment group.How Karwal, a native of India raised in Holland, ended up in Hong Kong and Singapore.[Listen Now]

Ram Palanki, PharmD, VP of commercial strategy and operations for REGENXBIO, has been involved in the development and launch of at least two groundbreaking treatments: Lucentis (ranibizumab, Genentech/Roche) and Macugen (pegaptanib).If all goes well in clinical trials, Dr. Palanki could soon add one more to his extensive CV: a one-time gene therapy designed to treat age-related macular degeneration and diabetic retinopathy (DR). A master of back-of-the-eye product development and commercialization, Dr. Palanki sits down with OIS podcast host Firas Rahhal, MD, to discuss the history of retinal disease treatments and the potential of gene therapy to address early- and later-stage disease.He hopes REGENXBIO’s lead product, RGX-314, helps resolve the adherence issues that plague anti-VEGF drugs, the current standard of care. Currently in Phase III trials, RGX-314 introduces a trans gene that can encode for a therapeutic protein for life—a concept REGENXBIO is exploring for the first time. Clinical trials also show a potential benefit for DR. Interim data show about 50% of patients demonstrated a two-step or greater improvement in visual acuity from baseline at six months after a single dose.            Listen to the podcast today to hear Dr. Palanki and Dr. Rahhal discuss: What it was like to be involved in the groundbreaking Lucentis and Macugen launches.How REGENXBIO plans to solve the sustainability problem that arose with the advent of anti-VEGF therapies.The history, mechanism of action, and route of administration behind RGX-314, REGENXBIO’s lead program.The strength of RGX-314’s adeno-associated viral vector (AAV) and other novel AAV vectors (NAV) technology platform.The philosophy behind REGENXBIO’s DR program, including the potential of treating healthy eyes with RGX-314.How Dr. Palanki’s responsibilities differ between development and commercialization. Click “play” to listen.

OIS has showcased dozens of ophthalmic leaders who are part of Israel’s thriving biotech and medtech spaces. This OIS Podcast features one of those leaders, who’s preparing for MIXiii Health-Tech.IL, the annual gathering for the life science and health tech industries in Israel. It’ll be held in Jerusalem November 9 and 10. And for the first time, OIS Israel will be part of it.Podcast host Rob Rothman, MD (also an OIS Israel cochair), talks to Tarsier Pharma founder and CEO Daphne Haim-Langford, PhD. Dr. Haim-Langford gives an update on her company’s Phase III trial for TRS01, a drop designed to treat uveitis and uveitic glaucoma. The trial is 50% enrolled, she says. Meanwhile, Tarsier is conducting Investigative New Drug (IND)–enabling studies for TRS02, an injectable therapy intended to treat diabetic macular edema, dry age-related macular degeneration (AMD), and posterior uveitis.   Dr. Haim-Langford describes OIS Israel as a showcase for “groundbreaking developments that bring hope to ophthalmologists and patients” and notes that 27 different companies will present over the two days. Listen to the podcast to hear:The unique culture that makes Israel fertile ground for new technology as well as new drugs.How the ophthalmic culture in Israel allows for smooth collaboration between industry, medical centers, academia, and finance.How collaboration between these stakeholders differs from the US.Why publicly traded venture capital companies focused on ophthalmic startups have had success in Israel.Why now is the time for Israel Advanced Technology Industries (IATI) to hold an ophthalmic session at MIXiii. Click “play” to listen.

Rayner is best known for its intraocular lenses (IOLs). It developed the world’s first IOL and is the sole manufacturer of IOLs in the UK. The company currently manufactures 1.3 million lenses a year, but there’s more to the story. Rayner’s portfolio also includes a delivery system, ophthalmic viscosurgical devices, drops, and a digital health platform that captures  patient-reported outcomes.CEO Tim Clover discusses Rayner’s diversified focus and data-driven initiatives with OIS Podcast host Sophia Pathai, MD, PhD. They also talk about how Clover helped move the company in a new direction, which included tearing down one factory and moving into a new R&D, training, and production facility in Worthing, West Sussex, England.Clover also helped Rayner secure a partnership with Brussels-based HASA OPTIX, which manufactures single-use ophthalmic surgical instruments.Listen to the podcast to discover: The challenges of Clover’s transition from a nonexecutive director role to CEO, both individually and for the organization.What’s new with Rayner and how it plans to acquire real-world data from its lenses.Rayner’s new Peer2Peer initiative to engage with leading, high-volume, and emerging key opinion leaders (KOLs).Clover’s thoughts on nurturing the next generation of industry leaders.The gaps in the eye care device industry and how professionals can come together to affect change.What motivates Clover every day as a leader. Hint: It has little to do with innovation. Click “play” to listen.

As head of Sight and Sound Technology, the largest supplier and distributor of technology and devices designed for visually-impaired and blind individuals, Glenn Tookey wouldn’t be disappointed if he went out of business. But until there are cures for all eye diseases, he remains a strong advocate for his customers. OIS Podcast host Rob Rothman, MD, kicked off a lively discussion with Tookey that covers the company’s beginnings four decades ago, how he  evaluates new products, and how he plans to bring those products to more patients. Tookey’s tech industry career includes stints in telecom, data processing, and even pinball machine repair. In 2008, he saw a mobile phone designed to help people with vision loss. Inspired by the design and the purpose, he later bought Sight and Sound.As CEO, Tookey frequently evaluates new technology from emerging inventors and developers. He also readily advises on product design, market access, and other product launch elements for products that aren’t ready for prime time. Too often, he said, innovators fail to address pricing (too expensive), market access (no reimbursement), or usability (too obtrusive or complicated).Moving forward, Tookey plans to stay on top of new technology and widen the company’s reach. Connecting patients to products is as much of a challenge in the UK and Ireland as it is in the United States, but he’s hoping to change that. Tookey wants to raise awareness with ophthalmologists, occupational therapists, opticians, and teachers to promote referrals and to bring greater independence to the blind and visually impaired. Listen to this podcast to discover: What Tookey sees as the most exciting solutions for creating independence for the visually impaired and the blind.The potential for augmented reality and virtual reality in this space. The reimbursement challenges for visual impairment hardware, software, and services in the UK, Ireland, and the US.The biggest mistake inventors make when developing devices for the visually impaired or blind.Click “play” to listen.

According to the India Brand Equity Foundation, India is one of the top 12 destinations worldwide for biotech activity. Seed-stage venture capital firm Endiya Partners is a player in that space, investing in product startups solving global problems. One of its portfolio companies, Eyestem, is working to solve the problem of equal access to cell therapies. Its vision is to develop a scalable cell-therapy platform to treat incurable diseases and to democratize access to these therapies. With cell and gene therapies priced in the six figures, they’re out of reach for the majority of the global population. In this OIS Podcast, Eyestem CEO Jogin Desai and Endiya Partners managing director Ramesh Byrapaneni, MD, discuss the mission behind Eyestem and the progress it has made so far. Sneak preview: Desai tells host Sophia Pathai, MD, PhD, that Eyestem is laser-focused on scalability. Its lead asset, Eye-Cyte-RPE, designed to treat early-stage age-related macular degeneration, is entering first-in-human trials in Q4. Other products in development are aimed at retinitis pigmentosa and early-stage idiopathic pulmonary fibrosis. Listen to the podcast today to get the full story on the following:The Eyestem/Endiya perspective: Can democratized access truly happen? The Eyestem product pipeline and the interest it has already received from pharma.What separates Eyestem products from other cell and gene therapies.Endiya’s investment philosophy and the companies—including Eyestem—that align with that vision.Dr. Byrapaneni and Desai’s backgrounds and what led them to founding a VC and leading a cell therapy company, respectively. Click “play” to listen.

A market leader in Japan with a 130-year history, Santen is paving new roads in the US and China. Peter Sallstig, MD, MBA, Santen’s CMO and global head of product development division sat down with OIS Podcast host Paul Karpecki, OD, to lay out the blueprint. In less than 30 minutes, you’ll hear about the products and business strategies that will help Santen compete in these markets at a high level. And that’s not all.A true global leader, Dr. Sallstig speaks five languages fluently. Using one of them, he discussed Santen’s long-term plan, the strength of Santen’s leadership, and its latest developments. Here’s a glimpse:In 2020, Santen acquired topical ophthalmic specialist Eyevance Pharmaceuticals. In a similar vein, Santen recently launched Verkazia, a topical immunomodulator approved for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Santen also has multiple products for glaucoma in its pipeline. Tune in to discover:Dr. Sallstig’s path to becoming Santen’s CMO, which began in primary care and merged into ophthalmology and industry.The importance of good leadership and other product development lessons he’s learned along the way.The current vision for Santen, both globally and within the US market.The story of Verkazia, the first and only topical immunomodulator approved for VKC.Advice for others interested in pursuing an executive career. Click “play” to listen.

Michael Chiang, MD, director of the National Eye Institute, spent more than 20 years in academic research. Now, he leads an organization that supports that research by funding more than 1,500 research and training grants for projects that address vision impairment and blindness.A pediatric ophthalmologist who’s board-certified in clinical informatics, Dr. Chiang remains intensely curious and generous. “I succeed when the vision research field succeeds,” he says in this OIS Podcast. With host Sophia Pathai, MD, PhD, Dr. Chiang lays out NEI’s recently unveiled strategic plan. The plan hints at where NEI plans to invest its annual $860 million budget over the next five years and how it plans to continue moving forward with its “audacious goals.” Literally, the NEI’s Audacious Goals Initiative for Regenerative Medicine was established in 2012 to push the boundaries of retina science and restore vision through retina regeneration. It has funded $80 million in research to date, and there’s more work to be done.There’s also room to improve diversity, equity, and inclusion in science and medicine—another area Dr. Chiang is passionate about. His mantra for collaboration: Instead of “great minds think alike,” it’s “great minds think differently[CN1] .” Follow him @NEIDirector. Listen to this OIS Podcast to discover:More about Dr. Chiang’s background, which starts with electrical engineering and continues with ophthalmology and biomedical engineering.What’s inside the NEI strategic plan, including its revised mission statement, its “audacious goals,” and its priorities for the next five years.What’s involved in developing such a large-scale plan, from buy-in to contributor involvement to change management.How the NEI promotes equal access to care as well as diversity within scientific collaboration.Where he sees room for opportunity in the relationship between academic institutions, industry, investment, and government.How emerging researchers can stay at the leading edge of innovation over the next 10 years.Click “play” to listen.

European investment in ophthalmology MedTech is more opportunistic than strategic says Klaus Stockemann, managing partner of Peppermint VenturePartners in Berlin. With fewer venture capitalists focused on the market, they are more receptive to cold calls and impromptu pitches at medical conferences.That’s one of the many insights provided when new OIS Podcast host Sophia Pathai, MD, PhD, MPH caught up with three top-tier VCs who focus on ophthalmology devices and technology.After recalling their nonlinear backgrounds, Stockemann;  Diana Saraceni, cofounder of Panakes Ventures (Milan); and Jennifer McMahon, a partner at Seroba VC (Dublin) discussed the activity in the MedTech space as of late. One piece of news that got Western Europe talking: Belgium-based iStar’s strategic alliance with AbbVie.What else? The guests agreed that ophthalmology’s active, entrepreneurial spirit, the high demand for microtized surgical devices, and the strong M&A market all make for an exciting time to invest in ophthalmology.For those in need of their services, the guests offer a wealth of advice. McMahon recommends that business owner/innovators have a good grasp of their position in the market—not only what’s on the market now, but what might be in a few years.Saraceni stresses relevancy: name-dropping does not impress her. Instead, highlight the results you and your executive team have accomplished that relate to your project.Listen to the podcast for more insights, including:How aspiring entrepreneurs and early start-up founders can refine their pitch and approach to ensure the best chance of success.What makes ophthalmology devices an attractive investment area.What’s exciting now in the ophthalmology therapeutics and MedTech.The advantages of the ophthalmology community above other therapeutic areas.How the VC role has evolved over the past few years and the speakers’ vision moving forward.Their forecasts for the future of ophthalmology MedTech over the next 10 years.[Listen to the Podcast]

Orbis International has been a pioneer in preventing and treating avoidable blindness for forty years. While much of that work takes plane on its Flying Eye Hospital, the organization also uses advanced technology to bring quality care to individuals worldwide.Cybersight is the global nonprofit’s telemedicine platform. Through it, the organization offers 24/7 live peer-to-peer consults for specialists worldwide. Over 24,000 eye care practitioners have sought expert opinions through the platform, gaining access to mentorship and advice they wouldn’t have otherwise. Users can also access live surgical demonstrations, courses, and other training: its library is free for all professionals.Orbis also leverages artificial intelligence to help improve access to eye care. Cybersight consult supports AI-grading of color fundus images attached to consult cases. In seconds, a doctor in a remote region can get an interpretation of an image to aid in diagnosis of diabetic retinopathy, hemorrhages, glaucoma, and other conditions.These are just two of the many ways Orbis International continues its fight against avoidable blindness. As Hunter Cherwek, MD, vice president of clinical services for Orbis, makes clear: 75% of visual impairment is preventable and 90% of those preventable conditions occur in low- and middle-income countries.Hosted by Rob Rothman, MD, this episode covers these and other topics:How Cybersight democratizes technology-driven eye care.Cybersight in practice. Full-stack machine learning engineer Gabriella Lanouette describes how it’s used in the real world and how it lessens the burden for clinicians.How Orbis International is developing more globally representative datasets to eliminate geographical and other biases in research.Managing a non-governmental organization. Venture partner, consultant, and Orbis UK board of trustees member Sophia Pathai, MD, Ph.D., MPH, discusses how the board balances fiscal and fiduciary responsibilities with the organization’s mission.How Orbis fundraises at the corporate level, worldwide.How you can get involved. Hint: You don’t have to sit on a plane…[Listen to the Podcast]

A group of experts in AMD and geographic atrophy discussed two GA treatments in Phase III studies: Apellis’s pegcetacoplan and Iveric Bio’s Zimura.If approved, these therapies will potentially slow lesion growth and preserve vision in patients with GA. Because they require monthly or bimonthly injections, they may also dramatically increase workloads for already overtaxed retina specialists.David Boyer, MD, of Retina Vitreous Associates Medical Group, said they’ll adapt. Somehow. Tarek Hassan, MD, partner and director of vitreoretinal training at Associated Retinal Consultants, agreed, noting the current working model will have to change. Somehow. “If we think we’re helping our patients we’ll figure it out,” he said.For better or worse, the rollout could be a gradual one. New-onset exudation has been observed in both pegcetacoplan and Zimura. This may spook some physicians, the panel noted, and they’ll take a watch-and-wait approach. Even so, it’s an exciting development for a challenging condition.Listen to the podcast today to hear our panel of retina experts discuss these and other questions related to dry AMD and GA treatment:Who are the ideal candidates for the forthcoming therapies from Iveric Bio and Apellis?How do you convince asymptomatic GA patients to initiate and continue treatment?How will artificial intelligence play a role in building a case for these therapies?Why do some patients with GA experience exudation?How do researchers determine clinical endpoints for GA? How does foveal center point involvement play a role?How do you decide on a proper treatment path?What therapies, drug delivery platforms, and/or technologies on the horizon are you excited about?[Listen to the Podcast]Speakers:David Boyer, MD - Retina Vitreous Associates Medical GroupTarek S. Hassan, MD, Professor of Ophthalmology - Oakland University William Beaumont School of Medicine / Partner and Director of Vitreoretinal Training - Associated Retinal ConsultantsErin Henry, PhD, Executive Director, Head of Ophthalmology - NGM BiopharmaceuticalsJ. Jill Hopkins, MD, SVP & Global Head, Ophthalmology Development Unit - NovartisCaroline R. Baumal, MD, Professor of Ophthalmology, Co-director of Retina Service - New England Eye Center, Tufts Medical Center

OIS Podcast host Paul Karpecki, OD, sits down with Ashley Brissette, MD, who just launched an eye-focused cosmetic skincare line called Eye Revive by Daily Practice. Now assistant professor of ophthalmology at  Weill Cornell Medicine, New York Presbyterian Hospital, Dr. Brissette talks about her journey to physician and entrepreneur.We get to hear how the Canadian-born, one-time performing-arts student transitioned into medicine and made her way to New York City, where her roster of patients includes the New York Rangers and Savannah Guthrie of NBC News and “The Today Show.”After consistently being asked by female patients which consumer products were best for the skin around the eyes, Dr. Brissette decided to formulate the first and only 3-in-1 product to cleanse, hydrate, and remove makeup.This didn’t come without its share of challenges and lessons. Listen in to learn more about this impressive young ophthalmologist and new business founder.  Click “play” to listen.

Scientist, entrepreneur, and executive Thomas Chalberg, PhD, has developed or funded companies that have advanced complex gene therapy technology, a novel anesthesia delivery system, and a lens that helps slow myopia progression in kids. And that’s just the start.A leader in gene therapy development who is recognized by the World Economic Forum as a Technology Pioneer, Dr. Chalberg cofounded Avalanche Biotechnologies, which is now Adverum Biotechnologies. There, he built the Avalanche Ocular BioFactory, an adeno-associated virus (AAV)–based, proprietary, next-generation platform for the discovery and development of gene therapy vectors for ophthalmology.While much of his career has centered on gene therapy, one of his more recent ventures, SightGlass Vision, falls on the opposite end of the spectrum. The company has developed a novel spectacle lens design that helps slow myopia progression. Its foundation stems from research by the University of Washington, which found that high retinal contrast signaling leads to high myopia and that modifying that signaling could slow myopia progression.Dr. Chalberg also is founder and managing director of Polymerase Capital; founder and managing director of iRenix Medical, which developed a novel anesthesia delivery system used in conjunction with intravitreal injections; director of Chameleon Biosciences, a gene therapy–focused startup; and founder and CEO of Genascence Corp., a gene therapy startup developing products for musculoskeletal disease.In between all this activity, Dr. Chalberg caught up with Firas Rahhal, MD, to talk about—what else?—gene therapy, along with retinal disease and his history in the anti-VEGF market.Listen to the podcast today to hear: About Dr. Chalberg’s work at Genentech during Lucentis’ launch and early commercialization. The philosophy behind iRenix Medical’s anesthesia delivery system, which administers a cooling anesthesia via an automated injector. His thoughts on the safety and effectiveness of gene therapy and gene editing for ophthalmic indications and how he sees it evolving over the next several years. Will it replace monoclonal antibodies, serve as an adjunct, or neither? How Dr. Chalberg got started in ophthalmology and retinal disease specifically.Click “play” to listen.

Before joining BioLight Life Sciences, an Israel-based publicly traded venture capital fund focused on ophthalmology, CEO Yaacov Michlin considered starting his own healthcare VC fund. Instead, he now finds himself leading a smaller fund within a vibrant community of startups.Although it’s a publicly traded company, BioLight operates like many VC funds, working both with early-stage companies and as an acquisition partner. Of the former, BioLight helps entrepreneurs with brilliant ideas develop target profiles and a vision for their products’ pathways.With nine companies in its portfolio that span drug, diagnostic, and device, and both front- and back-of-the-eye therapeutic areas, BioLight encourages synergies within its portfolio and within the collaborative environment that Israel is known for.Companies to watch include DiagnosTear, a diagnostics company with a platform that analyzes tear fluid. The platform uploads analyses to the cloud, creating a closed-loop system, Yaacov says.Listen to this OIS Podcast with host Rob Rothman, MD to discover:The potential advantages of a publicly traded VC firm. How the tech transfer process works in Israel. (Yaacov is the former president and CEO of Yissum, the tech transfer company of Hebrew University, Israel’s largest research university.) How The Technion—Israel Institute of Technology and Technion DRIVE Accelerator fuel Israel’s startup environment.  How the financial relationship works between BioLight and its portfolio companies.  More on the BioLight portfolio, which includes ViSci, a glaucoma implant, and OphRx, a delivery mechanism for products such as cyclosporine.Click “play” to listen

Raj Agrawal, MD, talks about his dual roles: CEO and president of the medical mission group Retina Global; and VP at clinical-stage biopharma Rezolute, where he’s leading development of a noninvasive diabetic macular edema treatment.

It started with a call. First, a call from Abbott led Christian Roesky to an industry role after completing his chemistry PhD in Germany. Next, came the call that would shape Roesky’s career—from Alcon, where he discovered eye care was his “everyday joy and passion.”The most pivotal call, however, came from Novaliq founder Bernhard Günther, who convinced Roesky to take his emerging startup to the next level. As managing director and CEO, Roesky has led Novaliq through development of a novel pipeline. Most notably, NOV03 (perfluorohexyloctane), a therapy designed to treat dry eye disease caused by Meibomian gland dysfunction, has delivered what OIS Podcast host Paul Karpecki, OD, calls the “most impressive dry eye Phase III data I’ve ever seen.”In a single study, NOV03 met its two primary endpoints: total corneal fluorescein staining and visual analog scale dryness score at day 57. Its novel mode of action lies in EyeSol, a water-free solution that overcomes many of the limitations of existing therapies. The product protects evaporation for hours and has the ability to penetrate the Meibomian gland, possibly improving its function. Novaliq plans to submit data for Food and Drug Administration approval by July. Bausch + Lomb will manufacture and distribute the product in the US. Novaliq also plans to submit a New Drug Application (NDA) to the FDA in July for the  anti-inflammatory CyclASol.Listen to the podcast today to hear more about: The potential of a water-free therapy for dry eye disease.Why Novaliq decided to license NOV03 to Bausch + Lomb.How CyclASol, which contains cyclosporine, differs from existing products.What’s next for Novaliq after a hectic 2022.How Roesky broke the family tradition of academic chemistry.Click “play” to listen.

Jill Hopkins, MD, didn’t plan to end up in a global leadership position at one of the world’s largest pharmaceutical companies. But she got there in 2021, when Novartis recruited her to serve as its SVP and global head of the ophthalmology development unit. Dr. Hopkins moved from academia to the clinic to industry, not by muscling her way in, but by exploring opportunities that sparked her interest and fueled her passion. At each steppingstone, she had a hand in some exciting developments. At Novartis, she leads drug development for its mid- to late-stage portfolio, including both anterior- and posterior-segment therapeutics. She brings a depth of experience to the role that includes science, medicine, and academia, with stints at large companies and small startups.After 10 collective years at University or Toronto and University of Southern California, Dr. Hopkins moved to Retina Vitreous Associates. There, she worked alongside OIS Podcast host Firas Rahhal, MD, running the electroretinography lab and working on ciliary-derived neurotrophic factor clinical trials.Opportunities to join Genentech, UNITY Biotechnology, and then Roche followed, with each experience building on the other. At the latter, she was involved in the development of both Lucentis (ranibizumab) and Susvimo, the port delivery system with ranibizumab, before Novartis came calling.  Listen to the podcast today to hear Dr. Hopkins and Dr. Rahhal discuss:How Dr. Hopkins’ time in academia, the clinic, and industry allowed her to become a well-rounded professional.Her involvement in Susvimo from clinical trials through to commercial launch. What will endure among the numerous therapies and delivery systems in development for the posterior segment.  How the industry can rise above the high bar set by current anti-VEGF therapies. How artificial intelligence can and will help clinicians define and measure outcomes.The outlook for regenerative medicine for the posterior segment. Click “play” to listen.

William “Bill” Freeman, MD, has been at the forefront of intraocular drug delivery for more than 30 years, and he’s done so while also treating patients and teaching the next generation of eye surgeons. From sunny University of California San Diego, where he serves as distinguished professor, vice chair of ophthalmology, and director of the Jacobs Retina Center, Dr. Freeman pioneered new techniques and technologies now common in the field. In the early 1990s, at the height of the AIDS epidemic, he developed a surgical technique to repair detached retinas, a common complication of the cytomegalovirus (CMV) retinitis he was seeing in so many HIV/AIDS patients. He also found that he could repeatedly inject drugs into the eye with little-to-no systemic side effects. Dr. Freeman’s research not only pioneered a new way to treat CMV retinitis; it also led to a method of ocular drug delivery that’s now the standard of care: intravitreal injections.With the support of ongoing National Institutes of Health funding, Dr. Freeman continues to look at new ways to deliver drugs. Through Spinnaker Biosciences, which he cofounded with fellow UCSD professor, Michael Sailor, PhD, Dr. Freeman is exploring nanopores as the method of a customized, long-lasting treatment for wet age-related macular degeneration.The other company he cofounded, Nanovision Biosciences, focuses in part on developing an implantable nanotechnology device for patients with degenerative retinal disorders.With retina specialist (and mentee) Firas Rahhal, MD, Dr. Freeman discusses his career in academics, his relentless pursuit of innovations, and why San Diego is ideal for windsurfing and kitesurfing. Listen to the podcast to hear Dr. Freeman and Dr. Rahhal discuss: Dr. Freeman’s early career goals, including why he chose to specialize in uveitis and why academia is a good fit for him.What it takes to do well in academics. (Hint: Location matters.) How his work with HIV/AIDS patients led to developments that are now the standard of care.  The state of Spinnaker Biosciences and the science behind nanoporous silicon, which is key to its long-lasting delivery system. His thoughts on polymers used in ocular drug delivery. The global medical, and scientific contributions that have emerged from Dr. Freeman’s retina fellows.  Click “play” to listen.

New World Medical, maker of the Ahmed Glaucoma Valve, continues to innovate and maintain a steady pipeline without the cachet that comes with big-name partnerships.CEO Bilal Khan spoke with OIS podcast host Rob Rothman, MD, about assuming the lead role at New World Medical from founder Dr. A. Mateen Ahmed—Bilal’s father-in-law.While Dr. Ahmed and Bilal can “geek out” about glaucoma devices at the dinner table, it wasn’t that way 12 years ago. Bilal joined New World Medical in 2008 after working in finance and as an actuary. His lack of a medical background served him well, however, as it forced him to deflect responsibility rather than wear all the hats.His core focus these days is to carry out the mission established by Dr. Ahmed: preserve and enhance vision by delivering innovation to benefit humanity through safe and effective medical devices. That mission involves five components:• Empowering surgeons• Expand access to care• Treat employees well• Donate 10% of profits to charity• Support employees to go on mission tripsThat five-ingredient recipe has led to three FDA approvals over the past three years. In addition to the popular Ahmed valve, the company’s product line includes the KDB Glide for excisional goniotomy, the Ahmed ClearPath drainage devices, and most recently, the Streamline Surgical System, a single-use device for goniotomies.Listen to the podcast to hear Bilal and Rob talk about:• The newly launched Streamline system• How New World Medical has managed to stay private, and whether it will stay that way moving forward• The company’s commercial strategy and why it’s focused on glaucoma surgical• How Bilal balances market opportunity and mission—maintaining the company’s charitable focus while meeting the needs of shareholders• Why there’s little competition in the glaucoma valve space[Listen to the Podcast]

Multiple reports have shown that only about 11% of Phase I clinical trials make it through to regulatory approval. Business, says retina expert Pravin Dugel, MD, president of Iveric Bio, follows a similar trajectory. Success comes only after multiple failures. Dr. Dugel has enjoyed success as a retina surgeon, as a principal investigator, and as president of a biopharmaceutical company focused on developing therapies for retinal disease. He became a leader in his field partly due to his fearless risk-taking and his ability to learn from the times when those risks didn’t pan out. An immigrant refugee from Nepal who fled to Austria with his family, Dr. Dugel followed his brother to a boarding school in England, finished high school and college in New York, and moved to the opposite coast to complete medical school, a residency, and a fellowship in southern California.Taking a calculated risk based on what seemed like a promising market, Dr. Dugel moved to Phoenix, Arizona, to build his clinical practice, Retina Consultants of Arizona. Though it took years of trial and error, he succeeded in founding one of the most innovative retina practices in the country. He has also served as principal investigator in more than 100 clinical trials, including known products such as NeoVista and Beovu.With host Firas Rahhal, MD, Dr. Dugel talks about what he and other investigators learned from the NeoVista clinical trials that would inform future protocols. He also discusses the science behind Zimura (avacincaptad pegol), Iveric Bio’s therapy for geographic atrophy, a part of late-stage age-related macular degeneration (AMD). Zimura received a special protocol assessment (SPA) from the Food and Drug Administration, which may help expedite approvals. Trial results from Zimura’s GATHER2 studies are expected in the second half of 2022.Listen to the Podcast to find out:The MOA behind Zimura  and why it may have an impact on intermediate macular degeneration and wet AMD. How Dr. Dugel expanded his career from traditional academic practice to research physician to biopharma entrepreneur, and the one quality that helped him along the way.What went wrong with NeoVista and Beovu and what the industry can learn from these studies.Click “play” to listen.

 NovaSight is tackling one of the biggest unmet needs in ophthalmology: pediatric amblyopia, otherwise known as “lazy eye.” It’s the leading cause of vision loss in children. And despite innovations in virtually every other eye condition, the most common amblyopia treatment has remained the eye patch.NovaSight’s CureSight is a binocular treatment that lets kids do their favorite on-screen activities—movies, YouTube videos, homework—while the device’s eye-tracking technology and three-dimensional image processing algorithms go to work. NovaSight recently presented positive top-line data and expects to receive Food and Drug Administration clearance in Q3. NovaSight’s CEO, Ran Yam, spoke with OIS Podcast host Rob Rothman, MD, about NovaSight and how it’s meeting unmet needs in children. NovaSight emerged in 2016 after an engineer approached Ran with an idea for using a virtual reality headset to treat strabismus. They were introduced to Michael Belkin of Belkin Lasers, who encouraged the partners to focus on pediatric uses. They agreed. Ran then assumed the role of CEO, started fundraising, and guided the company through a successful Series A round. NovaSight now has one product on the market—EyeSwift, a diagnostic device—and another on the way. Both use optical image sensors, a pair of ActiveSight glasses, and a cloud-based monitoring system. The company is currently raising $15 million to $20 million to fund development of the second generation of EyeSwift and to research CureSight for myopia prevention. Listen to the podcast for an in-depth look at:  • Pivotal study results for CureSight as an amblyopia treatment device.• How physicians use CureSight and EyeSwift, including how they can monitor activity between visits.• What’s different about EyeSwift 2.0.• How CureSight addresses myopia prevention.• How an engineer with an idea connected with Ran and Belkin to launch a successful start-up.Click “play” to listen.

Patrick Tresserras Former CEO & founder, Avizorex Pharma (acquired by Aerie in 2019)In this episode of the OIS Podcast, Dr Robert Rothman is joined by Patrick Tresserras, former CEO & Co-founder of Avizorex Pharma which was sold to Aerie in 2019. Dr. Rothman hones in on Patrick’s unique ability to identify promising academic assets to address unmet medical needs. Patrick’s first start-up Avizorex was founded in 2013 based on a technology originated from research conducted by Professor Carlos Belmonte at the Institute of Neurosciences in Alicante, Spain. The science involved temperature-sensitive neurons in tear film regulation. Patrick convinced Professor Belmonte to partner with him and then went on to secure financing and assemble a team to transform Avizorex’s lead candidate AVX-012 (a selective TRPM8 agonist eye drop) from an early stage preclinical asset into a novel Dry Eye Disease product candidate.  Following positive phase 2 data, Patrick successfully structured an  acquisition deal with Aerie just prior to the Covid-19 pandemic. We also learn about Patrick’s next venture, another ophthalmic startup “Innerva” that is developing INE-01, an ocular formulation of a PIEZO2 antagonist as the active ingredient for treatment of ocular surface pain. Innerva’s lead asset INE-01 being developed under IP license from University of Tennessee Research Foundation.Listen in…

Long before pharmaceutical and medical device sales reps make their pitches to physicians, ophthalmic drug and device developers run their products through years of clinical trials. Most of the time, they turn to third-party vendors to get them across the finish line. One of the most important partners in that process are clinical research organizations (CROs), which manage all aspects of clinical trials from discovery through to regulatory approval and commercialization.With offices in southern California and India, CBCC Global, a CRO with ophthalmology expertise, provides a range of services to help drug and device companies take their products to the next level. Under the leadership of CEO Manoj Vyas, CBCC has expanded its U.S. and India markets and plans to strengthen its presence in Europe. Already well-versed in Phase I – IV clinical trials, CBCC plans to further diversify to offer preclinical support.CBCC also champions innovation through strategic relationships: it recently entered into a joint agreement with StepWise Medical, a health technology start-up accelerator that focuses on ophthalmology and optometry.With host Ehsan Sadri, MD, Manoj and Sanjeev Ganatra, CBCC’s Senior VP of Sales and Marketing, discuss what’s next for CBCC and why they appreciate the close-knit ophthalmology community. They also discuss what they gained from having a few good mentors to guide them — not unlike how they now guide operations for their clients’ innovations today.Listen to the podcast today to discover:What brought both Manoj and Sanjeev to CBCC and how mentorship helped move their careers forward.The road ahead for CBCC and its “sweet spot:” ophthalmology drugs and medical devices.The advantage of having U.S. offices near Orange County, CA, which boasts an impressive ophthalmology ecosystem.Steps to take early and often to stand apart in a competitive industry.[Listen Now]

Richel Liu, left a secure post as CEO of a comprehensive IT group to start a VC with a focus on early-stage ophthalmology and optometry companies. She’s now one of a growing number of successful women entrepreneurs in China,  a country that’s home to two-thirds of the richest women in the world.The move from IT CEO to eye care VC isn’t as dramatic of a detour as it sounds. To Liu, ophthalmology is a multidisciplinary therapeutic area—it involves not only medical device and clinical practice, but also advanced technology, the latter of which she knew well. She also saw the potential, as eye care applies to people of all ages, from the perfectly healthy to those with chronic conditions, she explains.With host Rob Rothman, MD, a practicing ophthalmologist and managing partner of VC firm InFocus Capital Partners, Richel shares how she transitioned from the top of the corporate ladder to running her own business. She also discusses the goals of her VC, Rimonci Capital, and why she believes its work will help improve eye health for people everywhere.Listen to the podcast today to find out:How she did it—From a student in engineering and economics, to enterprise CEO, to VC founder with an eye toward ophthalmic devices, Richel took risks that many individuals shy away from.The regulatory hurdles involved in getting a drug or device approved for use in China.The funds that comprise Rimonci Capital, including a business fund, an incubator fund, and a general fund for early-stage startups in ophthalmology and optometry.What “stifled” Richel about leading a large company in China.[Listen Now]

As president and CEO of LENTECHS, a clinical-stage ophthalmic device company on the verge of commercializing a new contact lens, Robin Sears applies the core competencies he learned while moving through the ranks at Johnson & Johnson and Allergan.As told to podcast host Paul Karpecki, OD, when Robin heard about the presbyopia lens developed by Melissa Bailey, OD, PhD, and Joe Barr, OD, he saw a tremendous opportunity to reshape the market. He started fundraising and turned a novel invention into a business.Because of the demand for a presbyopia lens, that business may soon take off. LENTECHS research showed 74% of presbyopes who wear glasses want a contact lens solution. Why aren’t they using one now? Visual compromise. Current lenses don’t resolve near, mid, and far vision well enough for this growing population.The LENTECHS lens, called APIOC™, is based on a new type of contact lens-wearing experience. The lens is suspended behind the upper eyelid, which allows the eye to move freely behind the stable contact lens. It’s like wearing progressives, but without the glasses. After successful clinical trials, the company is currently staging for commercial launch in late 2022.Listen to this podcast to discover:The LENTECHS MOA: How APIOC works with the eye’s anatomy rather than on the eye’s anatomy.How Robin helped build Allergan’s then-new dry eye product, Restasis, into a billion-dollar drop. While there, he also led multiple teams to achieve billions in sales.The common traits needed to lead startup, continuing success, and turnaround opportunities.The full story on LENTECHS’s rise from concept to company.What Robin learned from his earliest mentors: his father, a dairy farmer; and an MBA professor who literally wrote the book on taking biotechnology research from the bench to industry.

One of the most influential women in ophthalmology today, Adrienne Graves, PhD has exceled in nearly every aspect of the industry, from research to industry to nonprofits.While many know Dr. Graves from her executive experience—which includes eight years as CEO of Santen and board positions with over a dozen ophthalmology companies—she got her start as a scientist.Her work in visual neuroscience got the attention of Alcon, where she was hired to set up the company’s first Retinal Electrophysiology Lab. “It was the best decision of my life,” she tells podcast host Rob Rothman, MD (even though she did have to move from Paris, France, to Fort Worth, Texas). With support from her manager, Dr. Graves moved on and up through R&D to eventually become Alcon’s Director of International Ophthalmology.After closing her chapter with Santen, Dr. Graves went on to guide other companies and cofound Glaucoma 360, an annual gala and conference produced by Glaucoma Research Foundation. The hybrid 2022 event kicks off on Thursday, February 10, 2022.Tune in to the conversation between Drs. Graves and Rothman to discover:What inspired Dr. Graves to choose visual science early in her career and how that initial spark keeps her going today.The details on the venture philanthropy fund started by Foundation for Fighting Blindness.More about the broad portfolio of professional opportunities that comprise Dr. Graves’s career.Why it’s exciting times for biopharma company Iveric Bio, where she serves as Chairman of the Board.

Retina specialists have limited imaging and surgical tools to visualize the back of the eye. While technology has improved, the need for incredible precision is paramount. [MOU1] PulseMedica’s 3D imaging and surgical platform has the potential to deliver extreme accuracy through advanced imaging technology, AI-based decision assistance, and femtosecond laser pulses. (For those who don’t study lasers, a femtosecond is one millionth of one billionth of a second.)PulseMedica CEO Nir Katchinskiy, Ph.D., focused on these super-precise laser pulses during his doctoral studies. In the process, built a system that images the eye in 3D, in real time, and delivers laser treatment with incredible precision. For now, the company is focused on imaging to treat dry AMD, diabetic retinopathy, and floaters, among other possible applications.With business partner Lahav Gil, an entrepreneur with a 30-plus year career in medtech, Katchinskiy discusses his innovation and the challenge of expanding his focus from solely research and design to device development, business, and leadership.Listen to the conversation with Ehsan Sadri, MD to hear:What motivated Gil to join PulseMedica and the qualities that make Katchinskiy an ideal CEO.How Katchinskiy developed device that allows physicians to image the eye in 3D in real time and deliver finite laser pulses to treat eye disease.The scoop behind their newly appointed Chief Technology Officer, Geoffroy Rivet-Sabourin.The go-to-market pathway for PulseMedica: is it dry AMD? Floaters? Diabetic Retinopathy?

Daniel Chao, MD, PhD, spent a lot of years in the lab studying the nervous system of zebra fish and worms. No surprise, after earning his PhD in neuroscience, he wanted to move on.Ophthalmology reeled him in. After a residency and a fellowship in the field, he moved into a multifaceted research career that includes academia, biotech, and industry.As Senior Director of Translational and Experimental Medicine and Retina Clinical Lead for Janssen, the pharmaceutical arm of Johnson & Johnson, Dr. Chao designs and executes first-in-human and Phase II proof-of-concept studies for J&J’s assets. He’s also involved in developing biomarkers to help accelerate clinical trials and meeting with external partners.He knows where they’re coming from. In 2019, he spun out technology he developed at UC San Diego into what is now Visgenx and became one of its scientific cofounders. Visgenx therapeutics are based on ELOVL2 gene expression, which is tied to aging in the retina and other tissues.Companies like Visgenx, take note: Janssen Retina is interested in both internal development as well as acquisition or partnerships as a route to innovative treatments.Listen to the conversation with Firas Rahal, MD to discover:The tech transfer and other pieces involved in taking Visgenx from scientific concept to funded startup.The mechanisms behind Visgenx’s lead product.His thoughts on retina gene therapy and the top three challenges to wider-spread adoption.How he transitioned from academic researcher to Johnson & Johnson.The “hustle” involved in an academic research career.

A new generation of drug delivery technology is emerging, with new refillable, absorbable, and dissolvable drug delivery systems making their way through clinical trials and into the market. Large pharmaceutical companies, biotech firms, and device startups alike are all developing innovative alternatives to intravitreal injection.These systems are important for improving compliance and, as a result, patient outcomes. The ability to extend treatment duration also alleviates some of the patient and physician burden that comes with regular injections.To explore the latest advances in the ocular drug delivery space and their impact on patients and clinics, OIS brought together an A team of medical, venture capital, and industry experts.Listen to this podcast to hear our panel discuss: • Do longer-lasting therapies, injectables, and resorbables represent a new bar for existing technologies?• What’s in development at Bausch + Lomb, Aerie Pharmaceuticals, and Allergan/Abbvie?• How will these new delivery systems change the dynamics in the clinic?• What should companies starting to commercialize keep in mind to ensure success?

Brian Strem, CEO and Director of Kiora Pharmaceuticals, didn’t plan to become an executive, or even an entrepreneur, when he started doing translational research for publicly traded biotech company Cytori Therapeutics. But as his career progressed from the bench to business development to leading Bayon Therapeutics (acquired by EyeGate) and Okogen, he found himself following in his father’s footsteps: during his childhood, Strem watched his first mentor grow a textile business from the family garage to an industry leading company.Inspired by Dad’s passionate pursuit, Strem has overseen the development of Kiora’s three-product pipeline. Kiora recently shared topline results on KIO-101, a small molecule dihydroorotate dehydrogenase (DHODH) inhibitor, demonstrating early stage, promising clinical data in reducing ocular surface inflammation in patients with conjunctival hyperemia. The results give Kiora the data needed to move into Phase II studies.KIO-201, the company’s legacy product, is a chemically modified form of hyaluronic acid that’s moved through later-stage trials. Strem says the drop significantly accelerates the rate of wound healing compared to today’s standard of care.Listen to the podcast, hosted by Paul Karpecki, OD, FAAO, for the full story. You’ll hear:More about Brian’s journey from the bench to business, and from bioengineering to ophthalmology.A deep dive into Kiora’s three programs and how they meet unmet needs in eye care.The story behind the rebrand from EyeGate Pharma to Kiora Pharmaceuticals. What’s in a name?

A college detour away from medical school and into scientific research worked to the advantage of Lori-Ann Christie. Her career has evolved from academic researcher to pharmaceutical industry scientist and director to venture capital fund principal, with each role building on the one before.Christie recently joined Visionary Venture Fund, a capital firm that focuses on ophthalmology devices and pharmaceuticals. She assumed her investment-based role after seven years at Allergan, now part of AbbVie. Through all Allergan’s internal developments, Christie stepped up, asked questions, and learned from her mistakes. When Allergan integrated into AbbVie, she moved into a director role and got to experience all that comes after her work in the lab.With host Ehsan Sadri, MD, Christie talks about her career trajectory, what she’s learned along the way, and what’s on the horizon.Listen to the podcast today to discover:The difference between academic and pharmaceutical industry research and why scientific rigor matters.Her experience as part of Allergan’s diligence team.Why the eye is a great vehicle for experiments.Her take on emerging scientific and technologic advances that have the most potential.

The annual tradition of the Ophthalmology Innovation Year in Review continues for 2021with data on, NEI funding, venture deals, public offerings, M&A transactions, FDA approvals and phase 3 data. This time OIS Co-founder, Craig Simak switches seats with three of our podcast hosts: Firas Rahhal, MD; Robert Rothman, MD and Ehsan Sadri, MD. The three wisemen who also happen to be MDs and VCs, reflect on some of the more notable events from the “OIS Year in Review” (link) presentation while providing commentary and insights on what the data means for industry, physicians, investors and even patients. Be sure to listen in to the last podcast for the year and download the full report.     

Even the most experienced physicians encounter patients with conditions they can’t solve after multiple questions, tests, and treatments. Diana Driscoll, OD, has not only treated some of these patients successfully, she’s been one of them.On a trip to Costa Rica, Dr. Driscoll contracted a virus. Through 10 years of disability, she saw over 50 doctors, but still had no answer. Her son, who also contracted the virus, was bedridden for three years.Ultimately Dr. Driscoll was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS), an autonomic nervous system condition that causes symptoms ranging from lightheadedness to serious digestive issues to dilated pupils.She started her research into POTS by looking in the eye. What she found was a disruption to neurotransmitters caused by an immune response. After investigating further, she developed several nutritional supplements, including the patented Parasym Plus, which not only resolve nervous system function, but also resolve dry eye in many cases.Dr. Driscoll is now the founder and President of Genetic Disease Investigators and the Clinical Director of POTS Care, the only clinic in the world dedicated to treating the underlying medical causes of POTS. She’s also the founder of TJ Nutrition, Dr. Driscoll’s supplement company.OIS podcast host Paul Karpecki, OD, a dry eye expert who has run advanced dry eye clinics for over 20 years, has encountered patients with unsolvable symptoms. He leads a conversation with Dr. Driscoll that covers her journey, solving the unsolvable, and bringing a product to market that has helped bedridden patients get up and walk. As an ophthalmic bonus her products safely support normal tear production.Listen to the podcast today to hear:How Diana identifies patients that may be experiencing vagus nerve disruption and what doctors should know about Parasym Plus.An in-depth discussion on the connection between immunity, neurology and dry eye disease.Her advice for physicians and emerging entrepreneurs who want to bring a product to market.How she plans to get the word out about her businesses and the medical need behind them.

When you’re an entrepreneur building out a company, it’s not enough to hire people with expertise you don’t have. As Brent Jones, Chief Operating Officer of I-MED Pharma, says in this week’s podcast, you have to ask questions and listen to what your experts have to say.I-MED Pharma, a Montreal, Quebec-based company that offers a complete portfolio of dry eye disease products, is the latest stop for Jones in a career that includes sales leadership roles at Grieshaber, Alcon Laboratories, Santen, ISTA Pharmaceuticals and Bausch + Lomb.He’ll apply everything he’s learned over the past 30 years to help I-MED enter the U.S. market in early 2022. The company’s blended portfolio includes the entire dry eye continuum—diagnostics, drops (including BAK free), ointments, plugs, nutrition and an intense regulated pulsed light (IRPL) device used to treat dry eye disease due to meibomian gland dysfunction.I-MED’s holistic product line allows for what Jones calls a consultative approach. He’s developing a sales force with deep product expertise, as well as implementation specialists, to provide information for physicians, training for their staff, and maintenance to I-MED devices when needed.Join the conversation with podcast host Ehsan Sadri, MD, of Visionary Eye Institute to learn:How Jones pivoted throughout his career between start-ups and large corporations.How I-MED Pharma plans to tackle the fragmented, competitive U.S. dry eye market with a physician-centered approach.Full details on the I-MED product line.Jones’s advice for emerging eye care entrepreneurs.

OIS podcast host Paul Karpecki, OD, FAAO, caught up with OcuTerra Therapeutics CEO and CMO, Kerrie Brady and David Tanzer, MD, to discuss OcuTerra’s novel small molecule integrin inhibitor. Preclinical data impressed David enough to resign from his CMO role at Novartis to help develop OTT166, a topical agent that meets a clear unmet need for patients with moderately severe to severe nonproliferative diabetic retinopathy (DR).The standard of care for patients with DR is to simply watch and wait. Intravitreal anti-VEGF injections are an option when complications occur, but those introduce significant patient burden.Phase I data for OTT166 looks good, and patients can administer the drops at home.With $35 million in Series B financing secured, OcuTerra will move into Phase II clinical trials early next year, with the goal of dosing 200 patients for the study.Listen to the podcast today to hear Kerrie and David take a deep dive into the MOA of the OTT166 compound and the objectives for the Phase II study. You’ll also discover:The science behind the fluorination technology that enables OTT166.The story of how both Kerrie and David transitioned from medicine to industry. Kerrie entered the pharma and biotech industries after completing a PharmD program. Today she’s an “unrepentant entrepreneur.” David practiced as an ophthalmologist for 20 years before moving into executive roles at Abbott Medical Optics, Novartis, and now OcuTerra.David’s advice for physicians with industry aspirations, and Kerrie’s advice for aspiring entrepreneurs.

Even the most groundbreaking device won’t go far if doctors can’t easily implement that device into their practice.MacuLogix co-founder and Chief Technology Officer Gregory Jackson, Ph.D., developed a novel instrument, AdaptDx, that could detect early-stage AMD by measuring dark adaptation speed. But it took a major design overhaul and the addition of an artificial intelligence-based testing agent named Theia for eye care doctors incorporate that device into their practices.The current version, AdaptDx Pro, has performed over a million diagnostic tests to date. The company’s success stems from its customer-service focus and the commitment to deliver a product that’s “faster, better, smarter, cheaper,” says CEO Bill McPhee.With host Paul Karpecki, OD, FAAO, McPhee chronicles the evolution of AdaptDx, which shrank from a 45-pound desktop instrument to a one-pound headset with a virtual assistant. They also discuss how he helped MacuLogix overcome its commercialization challenges and the lessons he learned along the way.Listen to the podcast to discover:Dr. Jackson’s research, which led to the discovery of dark adaptation as a biomarker for AMD progression as well as the development of the AdaptDx prototype.How the physician shortage led to a subscription model and a multilingual TheiaThe marketing message that resonates with early adopters and early majority (they’re not the same).What led McPhee to become a six-time startup CEO.Hit “Play” to Listen.

Adrienne Graves, PhD, former CEO of Santen, opened this panel discussion by reiterating a sentiment expressed by surgeons, innovators, and investors: we’re in the middle of a glaucoma renaissance. The release of new devices, instruments, and pharmaceuticals has led to improvements in surgical procedures and other treatment options that promise to improve the lives of glaucoma patients.For this week’s discussion, originally recorded for the OIS Glaucoma Innovation Showcase, Dr. Graves corralled four ophthalmology leaders to discuss what’s new and what’s next in glaucoma innovation, how their companies stay resilient through the SARS-CoV-2 pandemic, and more.A glimpse: Jay Katz, MD, Chief Medical Officer of Glaukos, shared the latest news on the iDose® TR sustained-release travoprost implant and the iStent Infinite, an investigational device designed to reduce IOP in open-angle glaucoma patients.New World Medical, which focuses on glaucoma surgical devices, has three products launched and two in the pipeline. Santen,  developer of everything from drops to surgical solutions, is exploring new MOAs and preparing for Phase III clinical trials for PRESERFLO, a microshunt currently available in Europe and under FDA review. Allergan, part of AbbVie for a little over a year, has gotten DURYSTA, its biodegradable implant, into the hands of 2,000 physicians to date according to Ramin Valian.Listen to the full episode to hear the panel address the following:What would you like your company to focus on for glaucoma?How has COVID-19 affected your product development, marketing, and physician interactions?How are your companies part of the glaucoma solution?The podcast lineup includes:Adrienne Graves, PhD, former CEO of Santen (moderator)Jay Katz, MD, Chief Medical Officer, GlaukosBilal Khan, CEO of New World MedicalOmar Sadruddin, MD, Senior Medical Director of SantenRamin Valian, Vice President, Glaucoma, Surgical, Retina & Eye Care Portfolio-U.S., at Allergan, an AbbVie CompanyHit “Play” to Listen.

Many early-stage medical device start-ups seek acquisition to secure the financial and operational resources they need to obtain regulatory approval and secure market access.Michael Gertner, MD, founder and CEO of Olympic Ophthalmics, took the more difficult path: he developed and began commercialization of iTEAR®100 himself.His non-invasive neurostimulation device treats all types of dry eye disease, and he wanted to make certain it got into the hands of as many patients as possible — not ignored by a large acquiring eye care company.To do so, Dr. Gertner assembled a small but mighty team of investors and in 2017 launched Olympic Ophthalmics. iTEAR 100 received FDA clearance under the De Novo path in May 2000. It’s based on technology similar to what’s been used successfully in cardiology, orthopedics, pain management and other therapeutic areas: electrical pulses stimulate the external nasal nerve, which prompts tear production.Dr. Gertner and team are currently running a post-market study in patients with previously undiagnosed dry eye, using iTEAR 100 as a first-line treatment. The second generation of the device, which he says will be submitted to the FDA “shortly,” connects to a smartphone app, which allows for easier prescription management.Listen to the podcast today to hear Dr. Gertner and host Paul Karpecki, OD, FAAO, talk in depth about iTEAR 100, its path to clearance, and why he shifted his career from general surgeon to eye care innovator.Ground they cover includes:The hurdles Olympic Ophthalmics faced when obtaining market access, including a 30-day prescription restriction and COVID-19-related supply chain issues.Dr. Gertner’s career trajectory, which took him from medicine to medical devices (he is the first inventor on over 200 patents).How Allergan’s TruTear device, which it discontinued in 2020, influenced his work.His advice for other entrepreneurs on funding and moving through the regulatory process.

Throughout his career, Ramin Valian, Vice President of International Glaucoma, Reimbursement Pipeline, for Allergan, has stayed by the side of his mentors.Fresh out of college, where he earned degrees in Middle Eastern studies and Russian, he shifted his goals from working at the U.S. Department of State to joining his older sister at Roche. After learning the pharmaceutical industry ropes as a sales representative, he followed his supervisor, industry leader Joseph Schultz, to Johnson & Johnson and then Allergan.Holding various leadership roles over the past 15-plus years, Ramin has helped launch every one of Allergan’s glaucoma products. With host Ehsan Sadri, MD, Ramin discusses his tenure at Allergan, the acquisition by AbbVie, and his ability to adapt to change.When you listen to this podcast, you’ll also hear Ramin’s take on:The new frontier for presbyopia: the latest on AGN-190584, AbbVie/Allergan’s drop.The AbbVie/Allergan innovation pipeline, including a collaboration with REGENXBIO for gene therapy in the retina space.The four pieces of advice he gives to entrepreneurs and mentees.How he’s navigated a long career through mergers, buyouts, and other external pressures.

You’ve got a game-changing product. They want to back innovators like you. What’s the secret to a happy marriage? More importantly, how to you get a first date?Recorded during OIS Retina@ASRS in San Antonio, Texas, five pharma and finance leaders discuss their current areas of interest, how to secure crucial series A funding, and what’s on the verge of disruption.Tune in today to discover:What’s hot in retina: Dr. Guerard believes multiple compounds can co-exist in the market. A researcher with a great science-backed idea may only need five to ten percent of the market share to build a valuable company. Think niche markets like uveitis; a delivery model for anti-VEGF therapies that lowers patient burden, and gene therapies with clear targets and strong preclinical studies.Advice for early-stage companies: It takes more than great technology to secure funding. Entrepreneurs must have a well-planned roadmap and a solid team, Menzo says. What should that roadmap include? Tune in.Advice for later-stage companies: Dr. Guerard discusses the area where most startups fall short, while Dr. Rahhal advises on how to move to the next inflection point.Other topics covered:How and when to go public? SPAC or reverse merger or IPO?Corporate partnerships: how do you use regional partnerships as funding vehicles and to successfully navigate complex regulatory and reimbursement environments?What’s the next disruptor in retina?The podcast lineup includes:Emmett T. Cunningham Jr., MD, PhD, MPH, senior managing director at Blackstone Life Sciences (moderator)Fred Guerard, PharmD, CEO of Graybug VisionTsuyoshi (Josh) Chiwata, director of venture management for Santen VenturesAndrew Liu, vice president of global corporate development for Chengdu Kanghong Pharmaceutical GroupJason Menzo chief operating officer for Foundation Fighting BlindnessFiras M. Rahhal, MD, a partner at ExSight Ventures, senior partner at Retina-Vitreous Associates Medical Group in Los Angeles, and associate clinical professor of ophthalmology at UCLA Geffen School of MedicineHit “Play” to Listen.

If you want to predict eye surgery’s future, ask someone who pioneered the techniques used today.For this week’s podcast, Firas Rahhal, MD spoke with OIS Lifetime Innovator Award recipient Stanley Chang, MD, at the recent ASRS meeting about how the techniques he pioneered in the 1980s and 1990s have come full circle. Dr. Chang was the first to use perfluoropropane gas in the management of retinal detachments caused by scar tissue proliferation (PVR) on the retina. In the 1980s, he used SF6 and C3F8 gasses in vitreoretinal surgery. At the time, he wanted to find a longer-lasting gas. Today, drug developers want longer-lasting anti-VEGF therapies.The next cycle of innovation may bring a new gene therapy, drug delivery device, or compound that provides even longer-lasting benefits. To brings those therapies to market, however, Dr. Chang emphasizes that physician-researchers need strong scientific and corporate teams.Listen to this week’s podcast to hear Dr. Chang discuss:What drove the process for the use of perfluoropropane gasses and perfluorocarbon liquids used in retinal surgery.What he views as the future of eye treatment, and why he hopes patient benefit will prevail over dollar volume.The next step for tamponades used in retinal detachment surgery.LinkedIn: Dr. Stanley Chang pioneered the use of gas injection for vitreoretinal surgery. Listen to our latest podcast to hear Dr. Chang’s thoughts on retinal surgery’s past, present, and future.Twitter: Listen to the latest OIS podcast to hear industry pioneer Dr. Stanley Chang discuss retinal surgery’s past, present, and future. Listen Now:

How many patients have chronic dry eye symptoms that persist after you’ve tried every available therapy? They may have an imbalance between the peripheral visual tracking system and central fixation. Jeffrey Krall, OD, an optometrist in Mitchell, South Dakota, discovered the connection between this imbalance and the collection of symptoms associated with digital vision syndrome (DVS). He developed neurolens to test, diagnose, and treat those symptoms.  A life-long tinkerer who comes from a long lineage of optometrists and ophthalmologists, Dr. Krall realized that many patients’ headaches, neck strain, and dry eye symptoms stemmed from an overworked trigeminal nerve. The constant effort exerted by the extraocular muscles to correct eye misalignment stimulates the nerve, leading to pain and strain. OIS Podcast host Paul Karpecki, OD, speaks with Dr. Krall about his experience designing a lens that could correct eye misalignment. Though new to ophthalmic innovation, support from a few eye care and neurology experts helped him move forward, despite skeptics. Early clinical data has removed much of their doubt: In one study 83% of neurolens wearers reported improvement in DVS symptoms. Listen to the podcast today to discover: The organic evolution of Neurolens, including the support he received from eye care leaders such as Vance Thompson and neurologists Andy Corley (now neurolens chairman of the board). The technology behind Neurolens that allows it to measure 10,000 data points to identify and resolve misalignment. What Dr. Krall has found as a trigger for myopia and a possible solution. The Krall family history, which takes place primarily in Mitchell, South Dakota, and involves four generations of optometrists/ophthalmologists and close family bonds.

Baruch (Barry) Kupperman, MD, PhD, works as a consultant, professor, and benchtop scientist, but finds the most meaning in the dozens of patients he treats each week.With research interests in dry AMD and drug delivery, Dr. Kupperman held multiple roles in University of California Irvine’s Department of Ophthalmology before becoming the Roger F. Steinert Professor and Chair of the Department of Ophthalmology School of Medicine in 2017. Although he spends more time in leadership meetings these days, Dr. Kupperman still devotes time to the pursuit of science and medicine.OIS host Firas Rahhal, MD catches up with Dr. Kupperman after a rare two days off to discuss his career path, the current and future state of drug delivery, and what keeps him awake at night. Dr. Kupperman also discusses his residency and first fellowship (he completed three), which involved treating AIDS patients with retinitis. Administering eye injections to patients weekly — even seeing patients at home when they were too sick to visit the clinic — motivated him to help establish a drug delivery unit at UC Irvine to research more convenient ways to deliver treatments.Listen to the podcast today to discover:More about Dr. Kupperman’s background, his work with AIDS patients, and his purposeful detour into neuroscience.The evolution of drug development and delivery to date and his views on the current state of drug delivery into the retina. He also names the three most promising long-term developments in ophthalmic research.The breadth of innovation happening in Orange County and UC Irvine’s influence in furthering that innovation. The university’s Gavin Herbert Eye Institute spun off several companies, including Glaukos, which developed the first Micro-Invasive Glaucoma Surgery (MIGS) device, iStent, which is now FDA-cleared and commercially available. UC Irvine is also behind stem cell companies and many others.

You’ve got a great idea. Now what?It takes years of trial and error to move an ophthalmology product from concept to commercialization. But when you believe your technology could “change the future of cataract surgery,” you’ve got the motivation you need to keep moving forward. After nearly a dozen prototypes, Lexington, Kentucky-based Gary Wortz, MD, Chief Medical Officer of Omega Ophthalmics, has a product that’s producing strong data in early research. The Gemini Refractive Capsule reduces variables in the predictive effect of intraocular intraocular lens implants. The technology fits inside the natural capsular bag once the surgeon removes the cortex. The lens capsule, Dr. Wortz says, is the safest place to implant a medical device because the area has no nerve endings or blood vessels. The technology helps reduce posterior capsular opacification and stunts fibrosis.To date, Dr. Wortz says Omega Ophthalmics has about 100 devices implanted that are well tolerated. The company is currently evaluating next steps.Tune in now to listen to the conversation between colleague and friend Paul Karpecki, MD, and Dr. Wortz. You’ll discover:·         The implementation process for the Omega Gemini Refractive Capsule and the advantages of using “the most important real estate in the body.”·         How Gary balances his medical practice, entrepreneurial endeavors, family life, and personal time. Hint: learn the art of “no.”·         What he learned through nurturing a product to fruition: from the idea, through the “messy middle,” to commercialization.·         How Omega Ophthalmics raised funds without venture capital. 

Damon Burrows isn’t a scientist. And he didn’t start IACTA Pharmaceuticals, an early-stage drug development company, because he believed his discovery could change the world.He founded IACTA because he was free. Free from his role as general counsel at Scilex Pharmaceuticals. And free to bring life-changing ophthalmic therapies to market.When Scilex merged with Sorrento in 2019, he and a team of executives from Allergan, where he previously served as Vice President, Associate General Counsel, moved away from Big Pharma to focus on innovation. Early on, IACTA partnered with Ora Clinical, which gave it depth of reach in asset identification, while the powerhouse executive team he selected helped move those assets forward.As IACTA emerges out of stealth mode with positive early data on its lead product, host Rob Rothman, MD, caught up with Damon to discuss his career evolution, the ocular drug market potential, and IACTA’s promising clinical programs.The newest addition to the IACTA family, IC 800, an ocular pro-wound-healing analgesic, is already causing a stir in the eye care community. The drug system is based on DENKI®s (Dual Enkephalinase inhibitors), which aim to protect pain-inhibiting enkephalins from degradation. When enkephalins concentration increases, a physiological analgesic effect occurs.IACTA’s dry eye franchise, IC 265, is moving forward via a partnership with Hong Kong-based Zhaoke Ophthalmology Pharmaceutical Ltd. The company starts enrolling for U.S. and multiregional clinical trials soon.Listen to the podcast to learn more about:The details behind the IC 265 platform what makes it a tolerable anti-inflammatory.The mechanism of action behind IC 800, in development with Pharmaleads, and the formulation progress made to date.How Damon’s legal career led him to general counsel roles at Roche, Allergan, and Scilex.The sage advice Damon received from a colleague that prompted him to assemble a top-drawer leadership team.

France-based Théa Laboratories may be only 27 years old, but its legacy goes back 150 years. It reaches back to the 1870s, when ophthalmologist Paul Chibret became fascinated with trachoma. He would later help found the French Society of Ophthalmology. Five generations of Chibret doctors and entrepreneurs later, the Chibret family’s passion for eye care has led to the development of one of Europe’s leading eye-care companies. Now led by chairman Jean-Frédéric Chibret, MBA, the company remains independent, family owned, and 100% ophthalmology focused. While honoring those company values, Jean-Frédéric stays focused on growth. Revenue has increased from €150 million in 2008 to €600 million in 2020. The majority of that—75%—has taken place outside France. Théa’s next goal: commercialization in the United States.Listen to Jean-Frédéric’s “fireside chat” with Emmetrope founder Joseph Sullivan to discover:● Théa’s objectives for the next few years in both existing and new markets.● The progress Théa Open Innovation has made implementing licensing agreements and capital investments with early stage partners. The subsidiary has already signed agreements that help advance treatments for myopia, wet and dry age-related macular degeneration and macular edema.●  How Théa became a leader in Europe and how it plans to continue to use its business formula to tap into the U.S. market.

With its high concentration of talented engineers, innovators, and entrepreneurs, it’s no surprise innovation is thriving in Israel. Home to a growing number of biotech and engineering firms, Israel has established a thriving ecosystem for ophthalmology startups.This week’s podcast shines a spotlight on that ecosystem, as host Suzana Nahum Zilberberg, Vice Chair of Bio-Light Life Sciences and co-founder of healthcare advisory firm iL.factor, settles in for a series of six-minute chats with six Israel-based innovators.Tune in to hear emerging technology founders, industry leaders, and savvy investors discuss emerging trends, product advancements, and business developments in eye care.The lineup includes:Zack Dvey-Aharon, PhD, cofounder and CEO of AEYE Health, and Kester Nahen, CEO of Notal Vision. The two early startup founders discuss how disruptive technology can help clinic-based eyecare overcome its limitations. They also give sage advice for other entrepreneurs.Anat Loewenstein, MD, Chair, Department of Ophthalmology, Tel Aviv Medical Center; Professor of Ophthalmology, Incumbent of the Sydney A. Fox Chair in Ophthalmology, and Vice Dean of the Faculty of Medicine, Tel Aviv University in Israel, and Ron Schneider, CEO and cofounder of Beyeonics Surgical. The key opinion leaders discuss the advantages of translating defense technologies to medicine, and the key to a successful transition.Nahum Ferera, CEO and cofounder of EyeYon Medical, and Michal Geva, Managing Partner and cofounder of Triventures. Geva, the first woman to found and manage a VC in Israel, discusses the opportunities and challenges in Israel’s ecosystem. Ferera recently completed a successful first round and discusses how he made it happen—with the help of a global team.

Dutch Ophthalmic Research Center (DORC) is a world-leading retinal surgical instrument developer. Even so, CEO Pierre Billardon recognizes the company has a fair percentage of United States market share to obtain.To take the private equity-backed company through its next growth phase — the goal is to double its equity in three to five years — Pierre listened to DORC’s surgeon customers, strengthened its team, and improved DORC’s internal and external communication.While innovation remains a key driver for DORC, Pierre remains focused on developing practical solutions. One key example: DORC’s disposable flat vitrectomy lens, a favorite device of host Firas Rahal, MD. In this episode, Dr. Rahal speaks with Pierre about the technology behind TissueBlue, the only FDA-approved selective stain for the ILM, and why it’s superior to using ICG off label for ILM staining.You’ll also discover: ·         How Pierre’s success at HumanOptics, manufacturer of the CustomFlex artificial iris, has informed his position at DORC. CustomFlex is the first ophthalmic device to receive FDA Breakthrough Device designation.·         The engineering behind the EVA Phaco-Vitrectomy system and how it brings LED “light to the eye.”·         How Pierre plans to obtain and maintain market share in a competitive landscape and his vision for the future.·         Why he considers his current leadership role the “job of his dreams.”Listen Now !

Eric Schlumpf, president and CEO of Stuart Therapeutics, took a winding path to launch his South Florida-based eye care company. Along the way, he met academic researchers studying a family of collagen mimetic peptides that appeared to have a powerful reparative effect on many human conditions, including several in ophthalmology. Eric and his leadership team have moved in one focused direction ever since. In April 2021—about a month after receiving an $11 million Series A round of capital investment—Stuart Therapeutics got the green light from the FDA to begin Phase II clinical trials for ST-100, a topical drop designed to treat dry eye disease. The company is also researching indications for glaucoma and dry AMD.The product’s key API: that collagen peptide family Eric discovered, now patented as PolyCol™. In corneal wound models in mice, researchers found PolyCol™ produced complete healing to corneal tissues in 24 hours or less. The MOA is applicable across a wide range of ocular surface indications, from dry eye disease to corneal erosions and recurrent erosions.In this episode, host Rob Rothman, MD, speaks with Eric from his steamy home base to discuss the Stuart Therapeutics pipeline and the circuitous path that led him there—from electrical engineering to C-Suite roles in the waste management and telecommunications to growing early-stage start-ups.Listen to this episode to take a deep dive into PolyCol’s unique MOA and find out how a PolyCol-based product differs from other dry eye therapeutics. You’ll also discover: How Eric found the PolyCol™ family of collagen mimetic peptides (CMPs), how Stuart Therapeutics obtained patent protection, and how the company expanded its IP portfolio.How the FDA has responded to preclinical and clinical trial data so far.More about Eric’s unique journey to leading an ophthalmic drug development company and the common thread in his diverse resume. The secret to the successful working relationship between Eric and his cofounder, Chief Medical Officer Robert Baratta, MD, and how they collaborate in an intense, competitive environment.

Donald Korb’s myopia hasn’t affected his renowned ability to observe and to see what’s next.  The renowned researcher, inventor and thought leader in both optometry and ophthalmology is known for discovering and naming Meibomian Gland Dysfunction(MGD), now recognized worldwide as the primary cause of dry eye, and giant papillary conjunctivitis(GPC), a complication from contact lens wear. Those discoveries—not to mention all the other ocular-related conditions he named—changed the face of ophthalmology and optometry. But the most personally satisfying accomplishment was his first breakthrough: creating the first membrane hydrophilic contact lens. From there, he said to host Paul Karpecki, OD, his life took off like the lead character in The Secret Life of Walter Mitty: whatever he imagined came to reality. Listen to this week’s podcast for Dr. Karpecki’s in-depth conversation with Dr. Korb. In it, they discuss: How a visit with Polaroid led him to ocular photography and contact lens development. The animal that inspired the first soft contact lens. What it takes (and what it doesn’t take) to be a great inventor. Why treatment by design is the way forward for eye care.  

Visus Therapeutics has more than doubled its team in the past two years, including the appointment of six senior leaders in June. CEO Ben Bergo grew that team as the company’s lead product, brimochol, a prescription eye drop designed to correct near vision loss caused by presbyopia, approached data readouts in Phase II clinical trials. As Visus prepares to move into Phase III studies later this year, OIS Podcast host Ehsan Sadri, MD, caught up with Ben to talk business and brimochol.Of the former, Ben shared how his career has progressed from spinning out technologies for Harvard, to leading M&A transactions for Planet Innovation, to founding a company dedicated to eye health.Of the latter, Ben details brimochol’s strong performance at eight and 12 hours. The product uses a combination of two APIs: 2.75% carbachol and .1% brimonidine tartrate, with 100 ppm BAK. Visus also has a preservative-free formulation in development that does not include BAK.Listen to the podcast today to discover: How brimochol’s API combo achieves such durable response.The market potential for presbyopia treatment and how telemedicine can help grow that market.Other products planned for the Visus pipeline, including wound healing leads in preclinical studies.More about Ben’s career trajectory, which took him from sunny Melbourne, Australia, to less-sunny Seattle, Washington. He also gives advice for emerging entrepreneurs and business leaders.

If it hasn’t happened yet, just wait: the day will come when you have to use a larger font on the computer or hold the phone farther away to read a message. That frustrating condition, presbyopia, is a $3-5 billion market with limited non-surgical treatment options. LENZ Therapeutics is one company on a path to change that.In this podcast, president and CEO Eef Schimmelpennink speaks with host Ehsan Sadri, MD, about the progress of the company’s lead program, aceclidine. The drop is designed to restore loss of near vision without triggering ciliary muscles, and it produced promising Phase II data.As the company moves toward Phase III clinical trials, fresh off emerging from stealth mode with a $47 million Series A financing from Versant Ventures and RA Capital Management, Schimmelpennink reveals his larger picture for LENZ — without reaching for the reading glasses. Listen to the podcast to discover: Schimmelpennink’s views on the influence on compounding pharmacies for presbyopia treatments.The impact of Allergan’s miotics on this space.The potential benefits of these treatments for optometrists and ophthalmologists.What attracted Schimmelpennink to Presbyopia Therapies (now LENZ Therapeutics).What’s next for LENZ in the presbyopia market and beyond.

Jeannette Bankes, President and General Manager for the Global Surgical Franchise at Alcon, learned early in her career that she had an interest not only in the complexity of vaccine and pharmaceutical development, but also in the business that drove that development. Her combination of scientific passion and business expertise led Jeannette to become one of the first women with a scientist-technical background to hold a GM role at Boston Scientific, and to lead what is now a $5 billion-per-year surgical franchise within the world’s largest eyecare device company.Take a listen as Jeannette discusses with host Rob Rothman, MD, why she transitioned from the pharmaceutical industry to the medical device industry and how she developed the business acumen to succeed as a GM. She also shares what’s on the horizon for Alcon and why the company values their strategic partners.Pres Play and you will also learn:What a company like Alcon looks for in early- and late-stage innovation partners.How Alcon maintains its dominance despite fierce competition.How Alcon plans to utilize digital health and data science to improve phacoemulsification (phaco).The unsolved ophthalmic problems that Alcon plans to focus on over the next 10 years.

Legendary retinal surgeon and innovator Steve Charles, MD, has a long list of accomplishments. He’s performed more than 40,000 vitreoretinal surgeries, lectured in more than 50 countries, and operated in 25 of those countries. He’s also authored 150-plus medical articles and the go-to text, Vitreous Microsurgery, which is coming out in its sixth edition (with a complete rewrite of every chapter). Dr. Charles speaks five languages, has degrees in mechanical and electrical engineering, and was a fellow at the National Institutes of Health. He also has, at last count, 106 issued or pending patents. Dr. Charles has been in practice for 46 years and has no plans for retirement. He continues to perform more than 700 vitrectomies during his 52-week work year. He hasn’t been on vacation in 25 years, spends his nights, weekends, and holidays studying engineering or stem cell biology, doesn’t have a house, a wife, or pets, but instead he has jobs and that’s the way he prefers it. Click “play” and listen in on a fascinating discussion about:• How Dr. Charles’ background in engineering became the foundation for solving problems by building better medical and surgical devices. • How his relationship with industry began and why he chose to formalize an exclusive consulting agreement with Alcon over the past 30 years. • The many techniques and technologies that he has developed that have been adopted by thousands of surgeons around the world. • Where he thinks there’s room to improve in techniques and technology today.

Paul Ryb was a very successful investment banker when he suddenly lost his central vision at age 37, due to dry AMD. In this unique episode of the OIS Podcast, Ryb tells our host Rob Rothman, MD, that the sudden change presented a big problem for him because of his fast-paced life. He said, “I had a lot of risk profile responsibilities, and it was life changing for me in not just my professional career but also my private investment career.”Upon being seen by a top eyecare professional at Moorfields Hospital, he was told nothing could be done for the condition, which he found surprising and distressing.However, Ryb then made contact with a charitable organization, Blind in Business, which he says began the next chapter of his life. “They had solutions for what I basically term affectionately as the ability to live and succeed with sight loss,” Ryb said. “And that kind of positive energy is exactly what I needed to hear at that moment.”That positivity led him back into sports, where he had succeeded to the point of becoming world champion of Visually Impaired Tennis. But more importantly he learned how to conquer challenges in his career using technologies for the visually impaired.And now, Ryb has chosen to use his investment banking skills to help fund and develop ophthalmic innovations.Click play to hear Paul Ryb talk about waking up with vision loss, his path to overcoming the challenges, and how he plans to use his experience with adversity to improve future technologies in this area.

In this episode of the OIS Podcast, Gleeson tells our host Paul Karpecki, OD that early on he wanted to be an architect. Although he didn’t continue in that direction, Mark describes parallels between being an architect and developing pharmaceuticals. “Pharmaceutical and drug development are very similar to architecture in that you have to think long term, you have to understand what the customer needs are, what the environment is going to be like both from a regulatory as well as a payer perspective. Then you put the plans in place and go through the process to make sure everyone does their job, and ultimately have a sign off and approval.”Gleeson also talks about making big career moves and gives insight into drug development challenges and opportunities. Dr. Karpecki asks about AZR-MD-001, Azura’s lead product candidate, for use in meibomian gland dysfunction. Gleeson explains that the company is looking at MGD from a unique perspective, as a condition that should be treated like a skin disease. AZR-MD-001is a keratolytic, which he says is a very interesting class of compounds that has been utilized in dermatology for a long time.Click play to hear Mark Gleeson talk about drug development and his company’s unique approach to treating MGD!

Thomas Ruggia, President & CEO of Samsara Vision, has used his experiences as a a lifelong athlete to create a path to success. Part of that experience comes from playing football in college and now as an Ironman triathlete. In this episode of the OIS Podcast, Ruggia tells our host Ehsan Sadri, MD, that having “vision for what great looks like” and a “relentless work ethic” are top priority of a good entrepreneur, which he got from his football days. Family was another major influence in Ruggia’s life. “As the brother of a special needs person you learn to have a deep degree of compassion but also a sense of purpose”.Ruggia also talks about his excitement at the prospect of rolling out the next generation of Samsara Vision’s implantable miniature telescope, the SING IMT. Click play to hear Tom Ruggia’s fascinating story about growing up a self-proclaimed “Jersey guy” and how sports led to a career in eye care!

Euan Thomson, CEO of Zeiss Meditec, Inc., is passionate about using large-scale collaborations and large-scale sharing of data, with machine learning, to extract insights he says “will really move the needle on healthcare.”In this episode of the OIS Podcast, Thomson and our host Ranya Habash, MD, discuss how the Covid pandemic accelerated the use of telemedicine and remote collaboration, and the trends that may continue going forward. Thomson says artificial intelligence is very logical for use in ophthalmology, due to the number of images used, but also because there is “less of a barrier to entry” for AI here than in some other fields. He also says telehealth will have a role with remote testing and monitoring. Thomson said Zeiss sees digital technologies as the future, both from a device and platform standpoint, and said, “When I think about digital it really is the ability to connect from anywhere, operate in a different way, streamline your workflow, and then ultimately when you do have data at scale and you can figure out new insights from that data, we start to improve patient care in some really big ways.”Click play to hear Euan Thomson talk about how digital technologies and large-scale sharing of data will bring big changes to healthcare.

John Snisarenko, COO, Oyster Point Pharmaceuticals, developed his interest in eye care at age 13, upon being fitted with contact lenses by an optometrist. That interest led him through positions with several eye care companies, and eventually to Oyster Point Pharma, which Snisarenko says has “a very unique approach to dry eye.”In this episode of the OIS Podcast, Snisarenko talks with our host Paul Karpecki, OD, about building a startup, moving through a successful IPO, and getting to a position of having a product ready to commercialize such as Oyster Point has done with its nasal spray OC-01. He said, “Be prepared to roll up your sleeves, and sometimes you’re building the plane as you fly it.”Snisarenko also talks about the importance of developing a good corporate culture, and says at Oyster Point two main credos are:Follow the scienceThink about the patient first“If you do those two right,” he said, “Follow the science and really follow the patient journey, the other things fall into place.”Click play to hear John Snisarenko share his experiences in the eye care industry, and how other innovators can apply what he has learned!

Chuck Hess, VP & General Manager, US Surgical, Bausch + Lomb, says the partnership between clinicians and industry in ophthalmology has been a fruitful relationship. His experiencing in working with surgeons began early in his career, spending time in the operating room with what he calls “some of the greats in all of ophthalmic surgery”, and using his engineering background to develop surgical instrumentation to address their unmet need. In this episode of the OIS Podcast, Hess tells our host Firas Rahhal, MD, “That in and of itself is really the inspiration I have day in and day out. Just understanding the importance of the things that we do, to provide the machines, to design the new technologies and the techniques, to develop digital solutions for longer term care, and really finding ways to change the game in this industry.”Hess discusses B&L’s current activities, and also areas he’s excited about for the future, including• Improved analytical and digital tools• Hypersonics• Robotics• New technology for the company’s cloud-based Stellaris Elite system • Improving efficiency in workflowHess predicts the next 10 years will be the most exciting in the companies history, and said, “I think the changes that we’re going to see in the next 10 years are going to dwarf the changes that I’ve seen in the past 37.”Click play to hear Chuck Hess talk about his passion to design, innovate, and bring great ideas to market!

Michele Garufi, Co-founder, Chairman, and CEO of Nicox, has done whatever was needed to get the company where it is today, with two promising product candidates in their advanced pipeline, as well as two out-licensed products. When it was time for Garufi to launch Nicox, there was no venture capital presence in the healthcare sector in his home country of Italy. So he and his Nicox co-founders looked outside the country, and found financing in France. They kept their research center in the Milan, Italy, area, and now have a development center in the United States. In this episode of the podcast, Garufi tells our host Rob Rothman, MD, that Nicox will continue to become more U.S.-centered, and completely focused on ophthalmology. The company was founded on Garufi’s interest in nitric oxide (NO) donation, trying to apply NO properties to different therapeutic areas.Garufi credits some of his ability to overcome obstacles to his competitive swimming days.  “When I was young,” he said, “for 7 or 8 years I was on the national Italian swimming team, and went to the World Championship. I had a great experience but with great sacrifice and a lot of resilience.” He pointed out that in a sport like swimming you train for a long time, with one goal, perhaps a major championship, which may or may not end well, and said this is not unlike pharmaceutical research, where after years of effort, a drug may not work. This was part of the story of Nicox.Click play to hear Michele Garufi tell the whole story!

Stuart Abelson is President, Chairman, and CEO of Ora, a contract research organization (CRO). He is also the son of an ophthalmologist, and says watching his dad’s hard work and passion still fuels him today. In this episode, Abelson explains to our host Rob Rothman, MD, the role of a CRO in conducting clinical trials for innovative companies. He said, “A lot of times these companies have the idea, they’ve got the product, they’ve got the know-how, but they tend to outsource the heavy lifting to get that done.” Abelson said a CRO handles the mechanics of getting a clinical study done, including:• Patient recruitment• Site Training• Oversight for compliance issues• Drug logistics• Data management and handling• Data interpretationHe says though that because of years of experience focusing only in the area of ophthalmology, the company does more than a traditional CRO and can help clients from large companies to physician entrepreneurs develop their studies to really help advance products through development. Another important point discussed is financing for a study, and Abelson explains how Ora’s experience and network can help identify sources of capital and potentially shorten timelines.Click play to hear Stuart’s insightful discussion on how Ora helps companies with their clinical studies!

When Alcon spun out of the grasp of Novartis, the company’s relationship with physicians around the world needed repair, according to Michael Onuscheck, president, global business and innovation at Alcon. “There was a separation between what the company was doing, and what the physicians and the community really needed us to do as leaders in the industry,” he said.In this episode of the OIS Podcast, Onuscheck tells host Ehsan Sadri, MD, that he sat down with physicians and listened to them to learn how to rebuild the relationships and restore customer value. He says Alcon’s responsibility as a leader in the segment is to understand what physicians need, and turn their ideas into products.Onuscheck discusses his path to Alcon, including a decision to target his career toward technologies that lead to immediate perceptible outcomes for patients. He says it’s “pretty unique” to work in a field where patients experience such an immediate difference after a procedure. He also outlines his current strategic responsibilities with the company, determining:• Where to take the company.• Where to make investments.• How to continue the growth trajectory shareholders expect. • What start-ups to consider for potential M&A or BD&L deals.The discussion includes the effect of COVID-19 on the eye-care market, the importance of mentorship, and, finally, some pearls for start-ups to consider, such as:• Determine where strategic gaps exist.• Be sure there is intellectual property behind the ideas you consider.• Have relationships with other companies, investors, and mentors.• Don’t be afraid to kill a project if it has a problem that can’t be solved.Click “play” to hear these valuable insights from Michael Onuscheck!

Nicholas Curtis, CEO of LENSAR, got some of his entrepreneurial spirit seeing his grandfathers (“pappous” in their Greek homeland) and father own and operate bars and restaurants. A football scholarship took him to Northwestern University in Chicago, and the rest has been what he calls “a circuitous route, with some serendipity.”Curtis traces his route in this episode of the OIS podcast, through his first job, at IBM, where he was trained in the company’s philosophy of a needs satisfaction approach to selling. He said, “It was all about building a relationship, and ultimately earning the right to ask for the business.”That position led to one with American Hospital Supply, where Curtis met Bill Link, (now Managing Partner of Flying L Partners), who became president of American Medical Optics (AMO) and recruited Curtis to join him. Curtis later joined Lensar as chief commercial officer, and was named “interim” CEO in 2012. Lensar is currently developing the Ally system, which Curtis says is “the first femtosecond laser for cataract surgery that integrates a next-gen laser with a Swiss-engineered phaco-emulsification device in a very small compact cataract treatment removal system.” The company is looking to file a 510K early in 2022, and hopes to bring the product to market in the 2nd part of 2022. Curtis also discusses tips for being successful including:Teamwork is important, members should share corporate valuesSurround yourself with good peopleHave respect for different points of viewAlways have integrityBe customer focused, meet customer needTreat customers as partnersDon’t be afraid of making a mistake, but moving on is criticalClick play to hear Nick Curtis describe his ongoing business path!

Arthur T. Suckow, PhD, became CEO of DTx Pharma through a path that taught him what he needed for this position, but before taking the title he had to prove to himself that he was ready. A recently completed series B financing of $100M and a growing team of executives, are solid evidence that he in fact was. In this episode Dr. Suckow tells host Firas Rahhal, MD, how his time spent working at Johnson & Johnson, AstraZeneca, and Regulus Therapeutics gave him the inspiration, and the different pieces of the puzzle that he needed, to focus his attention on the challenge of drug delivery, specifically using fatty acids. He explains the work DTx is doing with small interfering RNA (siRNA) on the delivery of RNA therapeutics, and explains that fatty acids can bind to albumin, which can be used as an “Uber” to maintain exposure of drugs over prolonged periods of time.DTx is first developing a treatment for retinitis pigmentosa, but Dr. Suckow said, “I’ve been a drug hunter my whole career,” and the company will be looking to develop products for other indications both in and outside of the eye.Click play to hear Dr. Suckow talk about all this and much more!

Balamurali "Bala" K. Ambati, MD, PhD, MBA, is in the Guinness Book of World Records as the world’s youngest doctor, having graduated from medical school at age 17. In this episode, Dr. Ambati explains to our host Paul Karpecki, OD, that this accelerated pace gave him a head start meeting great people, exploring the field, doing deep dives in research, and building a good network.Dr. Ambati has had diversified roles over his career, and said, “It’s been great to meld clinical work with research. When you take the patch off somebody, that smile of them seeing again is something special.”In addition to owning an ophthalmology practice in Oregon, Dr. Ambati is President [of iVeena Delivery Systems, a company Dr. Karpecki says is ”really making incredible strides in advancing a treatment for keratoconus”.The company’s candidate for treatment of keratoconus is IVMED-80, which has received orphan drug designation from the FDA. IVMED-80 is designed to restore the activity of lysyl oxidase (LOX), an enzyme responsible for natural collagen cross-linking in the cornea, which has been shown to be deficient in keratoconus patients. The company is also developing IVMED-85, for the treatment of myopia. Both drugs deliver copper to the eye, which increases LOX activity in both the cornea and sclera. iVeena’s research started years ago with an experiment in corneal cells, comparing donor corneas to corneas of patients that had keratoconus. Dr. Ambati said, “The journey from idea to impact is a long one that requires patience and perseverance. I think it’s key initially to secure the IP or the good patent attorney and put a team together around you to develop the business and the product.” Dr. Ambati gives a few tips for successfully moving from concept to Phase 3, including:Bring the right people together.Decide what you need to raise money for.Decide what to spend that money on. Raise enough money to get you through a phase 1/2a study. Show that there are leaders in your field that are willing to back you.Click play to hear Dr. Ambati discuss his fascinating journey!

In this episode “serial entrepreneur” Mina Sooch, President and CEO at Ocuphire Pharma, talks with our host Firas Rahhal, MD, about her experiences of “starting things, building things, and hopefully creating exits.”She says, “An important quality in innovating is the desire to take an asset that’s under-appreciated, add value and showcase that, and bring that to patients”.Because she’s held different roles over her career, Ms. Sooch is able to consider different points of view about what’s needed to build a company at each stage (i.e. gaining capital and finding the right talent). She describes lessons learned, including:• Bringing in the right KOLs, with appropriate experience to leverage.• Diversifying your assets, two are better than one.• The later the stage the better – and why.Sooch also describes Ocuphire Pharma’s pipeline assets including:• Nyxol - an ophthalmic drop that restricts the pupil, being targeted for three separate indications—reversal of mydriasis, presbyopia, and night vision disturbances.• APX3330 - an oral tablet targeting treatment of DR and DME.• APX2009 - being investigated for use in wet AMD.Click play to hear Mina’s great insights!

This episode of the OIS Podcast was a featured panel discussion with the following industry executives from the Dry Eye Innovation Showcase. Paul Karpecki, OD, FAAO, moderates the conversation with:Doug Faunce, PhD, Allergan/AbbVieSajjad Roshanali, Johnson & Johnson VisionRob Kissling, MD, Bausch + LombMark Hagler, Sun PharmaJehan Tamboowalla, NovartisThe panelists shared candid insights on:- The main driving forces and opportunities in this specialty.- How their companies plan strategic moves, and what they look for to expand their current portfolio of dry eye therapies.- Challenges they are encountering and strategies to overcome them.- The value of developing point-of-care diagnostics.- Initiatives to raise awareness of doctors and consumers. Click play to hear these valuable insights!

For this week’s episode of the OIS Podcast we are sharing the “Clinical Perspective” panel discussion from our recent Dry Eye Innovation Showcase. The following KOLs delivered some fascinating strategies on addressing this massively underserved patient population. Ashley Brissette, MDAna Alzaga Fernandez, MDCynthia Matossian, MD, FACS Laura Periman, MDYuna Rapoport, MD, MPHRahul S. Tonk, MD, MBAPaul Karpecki, OD, FAAODiscussion points include:• The complexity of dry eye disease• Identifying the root causes.• Optimal treatments for varying conditions.• The importance of educating patients.Click play to get enlightened!REGISTER for our next ophthalmology conference today http://bit.ly/2yFA6cv.

In this episode of the OIS Podcast, Tracy Valorie tells host Ehsan Sadri, MD, that one of the most important things in business relationships is building trust. She explains that you can’t always make everybody happy in a business situation, but if you come at it from a strong place of trust you can make something exciting happen.Valorie knew in 7th grade that she wanted to explore science, and her interest led her into several roles at Pfizer Labs, and eventually to the position of senior VP and general manager of ophthalmology at Bausch + Lomb. She now serves as a consultant to small ophthalmology start-ups, with an eye toward leapfrog technologies. In addition to discussing her experiences with large companies and start-ups, Valorie outlines how she moved through her career and gives tips on how others can outline their own path, including not to be afraid of taking the next step. Click “play” to hear this fascinating talk!

Our newest host, Rob Rothman, MD is shaking things up to bring fresh voices and ideas to the OIS Podcast. In what turned out to be the most fascinating podcast discussion to date, we had the privilege to speak with Bruce Ksander, Associate Professor of Ophthalmology at Harvard Medical School, who has also contributed to the highly-acclaimed book, Lifespan. Bruce opened our eyes, dropped our jaws, and completely blew our minds with research being conducted on reprogramming damaged cells to reverse the aging process. Tune in now for this mind-expanding and thought-provoking discussion around the future of regenerative medicine and the impact on age-related eye disorders.You don’t want to miss this conversation -press play to listen!

On this special episode of the OIS Podcast, we’re sharing the panel discussion from our recent Gene Therapy Innovation Showcase. We have Peter Francis MD, PhD from 4D Molecular Therapeutics; Jeffrey S. Heier, MD of Ophthalmic Consultants of Boston; Arshad Khanani, MD of Sierra Eye Associates; Jose-Alain Sahel, MD, of UPMC Eye Center; and Glenn Yiu, MD, PhD, from UC Davis Health. Our panelists assess the current landscape of gene therapy and addresses how the sector is evolving to go far beyond treating only inherited retinal diseases. They discuss promising clinical trials and how the future could transform to benefit many patients outside of retina thanks to new advancements.Press play to listen in!

On this week’s episode of the OIS Podcast, Robert Rothman, MD, is joined by Vince Anido, Chairman and CEO of Aerie Pharmaceuticals. Vince shares his vision for Aerie, and how his lean, efficient team carefully strategizes every move they make to cultivate products that benefit patients. We learn background on both Vince and Aerie, and how two of Aerie’s products, Rhopressa and Rocklatane, were brought to market in under one year. How has Aerie has made a name for themselves globally within glaucoma, and next in dry eye, and retina?

On this week’s episode of the OIS Podcast, Firas Rahhal, MD, is joined by Calvin Roberts, MD, CEO of Lighthouse Guild. Cal has over 36 years under his belt in the eye care sector ranging from academia, private practice, and industry. He shares the positive and the negative of transitioning from a private practice on Park Ave over to being the Chief Medical Officer of Bausch + Lomb. Listen in for important factors to consider such as autonomy, security, and the impact on those around you when considering the leap over to industry. We’ll also learn how Cal is weaving his previous experiences into the work he is doing for Lighthouse Guild and how they strive to reduce the burdens of vision loss for patients.

This week on the OIS Podcast, Paul Karpecki, OD, FAAO, speaks with the new CEO of TearClear, Robert Dempsey, to uncover what has been necessary for him to succeed in the space. Listen in as Robert discusses the importance of assembling a trustworthy crew before zeroing in on goals and objectives. Learn how his professional experiences have helped him build out a unique Medical Advisory Board for TearClear comprised of 50% optometry and 50% ophthalmology and what the future of TearClear looks like. Press play now and learn from one of the best!

We have a great conversation for you this week on the OIS Podcast: Paul Karpecki, OD, FAAO, joins Kim Brazzell, PhD and Chief Medical Officer at Kala Pharmaceuticals, to discuss Kim’s experience developing EYSUVIS, the first FDA-approved prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease.Kim gives us tips for navigating the approval process and shares lessons learned since he started working in the space. You don’t want to miss this episode. Press play now!

This week on the OIS podcast, we have an exciting conversation between Ehsan Sadri, M.D. and Shervin Korangy, President and CEO of BVI Medical.Listen in as Shervin shares highlights of his professional evolution. He tells us how his unique path of living overseas and working on Wall Street has impacted how he thinks about building and managing teams, and how the impact extends to planning the next steps for BVI. His perspective is innovative, refreshing, and not to be missed!Would you like to be featured on our podcast? Visit OIS.net and click Get Involved to submit your information.

This week on the OIS podcast, Dr. William Link of Flying L. Partners leads a fantastic panel featuring five successful Ophthalmic investors who share the important lessons 2020 bestowed on the industry that can help you build out your 2021 portfolio. Special thanks to: Arjun Arora, Director, KKR; Ali Behbahani, MD, General Partner, NEA; Anat Naschitz, Managing Director, OrbiMed; Bruce Robertson, Managing Director, H.I.G. Capital; and Jeffry Weinhuff, Managing Partner, Visionary Venture Fund for sharing their insight and for spending time with us.Press play now and listen in on this innovative conversation!

This week OIS is “ExSighted” to bring you a candid conversation with the dynamic trio that formed ExSight Venturess: Our host, Dr. Firas Rahhal, is joined by his partners Dr. Michael Nissen, and James Murray, JD. to describe why two practicing physicians and a lawyer decided to launch a specialized fund focused on investing in early-stage ophthalmology start-ups. The group also talks about their investment strategy, existing portfolio, and where they see the market heading.

OIS Podcast host Firas Rahhal, MD, of ExSight Ventures and Retina Vitreous Associates sits down with not one but two members of Outlook Therapeutics’ C-Suite staff, Terry Dagnon and Jeff Evanson. We learn about what kind of collaborations and strategies are necessary behind the scenes at Outlook and learn more about the company’s road to bringing ONS-5010/Lytenava (bevacizumab-vikg) – potentially the only Food and Drug Administration-approved form of bevacizumab for the eye – to market. From studies, dosing, pricing, and other considerations, they cover it all. Press play now and listen in on this innovative conversation!

This week on the OIS podcast, Paul Karpecki, OD, FAAO of Kentucky Eye Institute sits down with Jerry St. Peter, Co-Founder, CEO, and Director of Eyevance. Together they take a look back at Jerry’s impactful career in Ophthalmology. Jerry shares pearls of wisdom around building businesses, wading through acquisitions, and talks about the importance of surrounding yourself with quality people to stay on the road to success. There’s something for everyone in this conversation- press play now!

This week on the OIS podcast, host Firas Rahhal, MD, Partner at ExSight Ventures & Retina Vitreous Associates Medical Group facilitates an illuminating discussion on the topic of retina start-ups with a focus on providing tips to anyone interested in joining the retina space.  Our guests include Andrew Stewart, AVP, US Commercial Retina of Allergan; Jay Duker, MD, Chief Strategic Scientific Officer, EyePoint Pharmaceuticals; Paul Hallen, VP & Global Head, Retina & Glaucoma, Alcon; and Ram Palanki, PharmD, SVP, Commercial Strategy & Operations, REGENXBIO.Listen in as this group shares advice on the topics of talent, asset quality, company strategies, and product development across the board. Learn what companies are looking for and where there is room for start-ups to flourish!

This week we’re bringing you a unique discussion that marries investments in Life Sciences and the field of Ophthalmology! Our host Firas Rahal, MD and guests Rob Rothman, MD and Ron Weiss, MD connect on this episode to discuss how two areas of interest converge in a symbiotic relationship that helps keep innovation at the forefront of Ophthalmology.

This week the OIS podcast touches on several topics within the realm of Glaucoma. We’re pleased to bring you this fascinating conversation hosted by Dr. Ehsan Sadri featuring guests Ike Ahmed, MD; Janet Serle, MD; Paul Singh, MD.This conversation covers proactive diagnostic technologies, approaches to both traditional and innovative therapies, and advancements that have defined the Glaucoma sector of medicine as we know it. Listen in to hear thoughts on cutting-edge solutions such as gene therapy and MIGS that hold the potential to help specialists manage both progressed and new patients.

This week we veer off the beaten path to bring you a unique panel discussion with industry leaders from Allergan, Santen, Genentech, and Aerie Pharmaceuticals. Each share expertise on drug development technologies and discusses insights on some of the hurdles they have had to overcome to successfully roll out products in pharma.

This week the OIS podcast brings you a thoughtful conversation with host Dr. Emmett Cunningham and guest Daphne Haim-Langford, PhD, Founder & CEO of Tarsius Pharma. Daphne takes us through her 20+ years in the Ophthalmology industry, complete with details about her latest clinical trials to tackle uveitis, the third leading cause of blindness.

This week we shift gears back to “R” for the OIS Retina Podcast with Dr Firas Rahhal and his esteemed guest Dr Steven Schwartz who raises the bar as a physician, an educator and of course an innovator. Steve shares his unlikely path into ophthalmology and how serendipity or luck surrounded him with great people which led to great opportunities. Steve shares an entertaining look at his career, the many start-ups that he’s had a hand in and the future of surgical robotics. If there’s one episode you want to listen to – this is it. 

This week’s guest is a Harvard-trained physician-scientist, inventor, entrepreneur, and serial innovator. The one and only Sean Ianchulev shares his story as an emigrant of communist Bulgaria who overcame many obstacles to become one of the top innovators in the field of ophthalmology. We learn why he committed to the uncertain winding path of innovation over the straight-line physician career/clinical practice. Early formative projects on digital diagnostics with the first virtual device for online perimetry and intra-operative aberrometry and understanding the role of industry/capital in taking R&D and discovery out of “neutral” and into over-drive to bring it to patients and physicians. And don’t forget about Eyenovia’s breakthrough technology for smart micro-therapeutics and the possibility to solve the global problems of progressive myopia and presbyopia...telemedicine and vision without boundaries...and innovation for global outreach and disease treatment. How he plans to change the equation of trickle down technology to the developing world where the biggest unmet need is.

In this wide-ranging discussion, Dr. Joe Boorady shares his perspective on the state of ophthalmic care today, his experience transforming powerful ideas into high-impact realities, and the spark that lights his entrepreneurial fire. Interviewed by Paul Karpecki, OD, this week’s conversation is one you won’t want to miss.

On this week’s OIS Retina podcast, we have the privilege of talking to Steve Pakola, MD. Steve is an industry veteran who has held key leadership roles in preclinical and clinical development, regulatory affairs, and medical affairs. Currently, he serves as Chief Medical Officer at REGENXBIO, a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy.

With a medical career spanning 35 years, including as global head of immunology at Sandoz (now Novartis), Patrik De Haes, MD, has cultivated deep experience turning scientific ambition into life-changing reality. In this unmissable episode, we talk to Dr. De Haes, now CEO of Brussels-based Oxurion, to get a deeper look at the business, research, and cultural elements that drive a product’s journey from concept to commercial.

This week the OIS Podcast hits a milestone with Episode 250. To mark the occasion, we feature a discussion with Tim Clover from the recent OIS European Innovation Showcase. Tim talks about his journey with Rayner and some significant changes he’s made since joining in 2014.  Listen in (or watch) to learn more about Tim and his vision for Rayner’s expansion as a dominant player in eye-care. 

This week, we sat down with Savas Komban, an industrial engineer, serial entrepreneur, and CEO at Smartlens, the first electronics-free soft contact lens that measures eye pressure and its fluctuations throughout the day. Join host Ehsan Sadri, MD for a riveting conversation on the future of glaucoma care.

Our podcast guest this week is Jay Duker, Professor and Chairman of Ophthalmology at Tufts Medical Center. Here, Dr. Duker shares his perspective on exciting clinical trials happening in the posterior space. He also offers words of advice for clinicians interested in running a practice while holding a senior position in industry. Have A Listen.  

This week’s podcast guest is Christian Roesky, a chemist by training who found a passion for ophthalmology and spent the bulk of his career in management roles with B+L, Alcon and Abbott before taking the leap into the CEO position at Novaliq in 2016. Christian provides an insider view of Novaliq’s platform technology to address various ophthalmic indications and shares some words of wisdom for other innovators.

No – not that apprentice. This week we had the pleasure of speaking with Todd Brady, MD/PhD turned VC/EIR turned CEO of Aldeyra back in 2012. Todd talks about how he transitioned from the lab over to the dark side back in the 90s when “Industry” was still a dirty word. Todd found his calling as a company builder who has since taken Aldeyra public and into Phase 3 trials with novel treatments for dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy. The company is also developing other product candidates for retinal and systemic inflammatory diseases. Listen in for some words of wisdom from the real Apprentice…

This week Dr Sadri is joined by Ram Rao, CEO of LensGen, who developed a curvature changing fluid lens to correct presbyopia. Ram tells his story from the early beginning while collaborating with the late, great Roger Steinert, MD and realizing that they had to go back to the drawing board to reinvent the technology.  Rather than throw in the towel after hearing no repetitively from investors, Ram persevered at all costs, subsequently raised $42M to date and emerged with a breakthrough technology to treat cataracts and presbyopia. Listen in for pearls of entrepreneurial wisdom and understand why Ram never took no for an answer.

Seasoned start-up and medtech executive, Rob Thornhill joins us on this week’s OIS Podcast. Rob sold Tear Film to Alcon in 2018 and is back in the saddle as the CEO of Centricity Vision. Dr Sadri has Rob discuss the benefits of the Zepto device in delivering automated, precise, circular, and centered capsulotomies, how their business model evolved during COVID and the future direction for the company.

This week, Firas Rahhal sat down (virtually) with none other than Mark Blumenkranz, who shares lessons learned the hard way which led to his proven “Innovation Recipe”. Mark also sheds light on the investing/incubating model for Lagunitas Biosciences and what he claims will be his final CEO role at Kedalion Therapeutics.

This week’s OIS Retina Podcast guest is French-born Patricia Zilliox, who boomeranged back to her homeland to become president and CEO of Eyevensys. Before that she’d spent 25 years with Alcon before joining the Foundation Fighting Blindness as chief drug development officer. When a family matter brought her back to France, she was introduced to Eyevensys through the investment group BPI France. Having spent so much time evaluating new therapies at FFB, she was intrigued by Eyevensys’ unique platform to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic disease. Needless to say, she took the CEO job and shares more details on Eyevensys’ lead product: a gene therapy to treat uveitis.

If there’s one podcast you listen to all year – this is it!Dick Lindstrom explains how saying “Yes” to opportunities, led him into an extremely gratifying and successful career in ophthalmology – which was the furthest thing from his plan to take over the family construction business.This episode is packed with gems of insights on building an academic practice and working with industry to balancing work and family. Ophthalmology’s leaders convene at the Ophthalmology Innovation Summits held several times a year. OIS Podcasts keeps the conversation going the entire year. In weekly podcasts, Host Ehsan Sadri interviews the most influential industry executives, investors, KOLs, and researchers about what they see as the most exciting approaches to finding new ways to treat eye disease. Join the conversation by subscribing to the OIS Podcast.

This week’s guest is Kenneth Mandell, MD, PhD, an ophthalmologist by training with a PhD in molecular biology who has been blessed with some amazing mentors who guided him into a fascinating career in ophthalmology. Ken’s educational and research pedigree includes: Tufts, Emory, Harvard, Johns Hopkins, and Massachusetts Institute of Technology; he also has an equally impressive corporate resume.Ken took his passion for biomedical engineering, combined with a spin-out technology from MIT and a grant from the Department of Defense, and used it to develop unique drug-delivery solutions for glaucoma, postoperative inflammation, and wound healing.

Host Ehsan Sadri, MD, is joined by Jeffrey Nau, PhD, who shares insights from a career in ophthalmology that has led to his current role as the CEO of publicly traded Oyster Point Pharma. In this interview, Jeff addresses some of the recent setbacks from COVID-19, conducting business virtually, different indications the company plans to address, and opportunities that lie ahead.

OIS Israel Co-Chair William J. Link, PhD, of Flying L Partners, shares some business life lessons and the unique sequence of events that led him into ophthalmology and eventually venture capital. Dr. Link also discusses the impact of COVID-19 on his portfolio companies and predictions on when and how we as an industry will come out of this. Don’t miss this highly informative and entertaining discussion between Ehsan Sadri, MD, and the man he calls “the Phil Jackson of ophthalmology.”

Elad Kedar, CEO of Orasis Pharmaceuticals shares his strategy for successfully completing a Phase 2b clinical study in preparation of their phase 3 of CSF-1 drops for temporary correction of presbyopia. Jeff Weinhuff from Visionary Ventures joins the conversation as Chairman of the Board to explain how he evaluated the Orasis technology and what VCs look for.

For this episode of the OIS Podcast, we are sharing a panel discussion on Leadership which took place during the last OIS@AAO meeting in San Francisco.The focus of the conversation was on “How to Measure and Motivate in a Startup Environment” and featured some valuable insights from Adrienne Graves, Bernie Haffey, Ron Kurtz, Kirk Nielsen, and Andy Corley.Participants:Adrienne Graves, PhD, Independent Board Member - Nicox, IVERIC, Oxurion, Akorn, Greenbrook TMS, Surface PharmaBernie Haffey, President - Haffey & Co.Ron Kurtz, MD, President & CEO - RxSightKirk Nielsen, Managing Partner - Vensana CapitalModerated By:Andy Corley, Principal - Yelroc ConsultingJoin us this year at the 12th Annual OIS – November 12, 2020 » Las Vegas, NVhttps://ois.net/12th-annual-ois

In January of 2020, Tarsus raised $60 million Series B financing round to initiate Phase 2b/3 trial in the U.S. of their lead product TP-03 for Demodex blepharitis. In this episode, Bobby Azamian shares his background and path to ophthalmology, details on their clinical trials and practical advice for entrepreneurs.Interviewer:Ehsan Sadri, MDManaging PartnerVisionary MD Eye Laser instituteGuest:Bobak Azamian, MD, PhDCEOTarsusAre you interested in being an OIS Podcast guest or interested in presenting at one of our upcoming showcases?Visit OIS.net for more info – https://ois.net/get-involved

This week’s OIS Podcast has breaking news on Robert Dempsey, the new CEO of TearClear, which came at the close of a Series B financing round. Listen to how he plans to take TearClear through the next stages of development.Interviewer:Ehsan Sadri, MDManaging PartnerVisionary MD Eye Laser instituteInterviewee:Robert DempseyCEOTearClearIf you are interested in being an OIS Podcast Guest or interested in being a Presenter at one of our upcoming showcases – Visit https://ois.net/get-involved

In this episode of the OIS Podcast we are sharing more “best-of” content from the recent OIS@SECO. Summit Co-Chair Emmett T. Cunningham Jr., MD, PhD, MPH, engages vision industry Titans in a discussion around their latest innovations for both the Ophthalmic and Optometric markets.Participants:Glen Curran, VP, Anterior Segment Marketing, US Eye Care - AllerganJohn Ferris, VP & General Manager, Vision Care - Bausch + LombKurt Moody, OD, FAAO, Director, Ocular Surface Disease & Professional Strategy - Johnson & Johnson VisionAndy Pawson, President & GM, Global Vision Care - AlconPaul Smith, VP, Business Unit Head, Eye Care - NovartisModerated By:Emmett T. Cunningham Jr., MD, PhD, MPH, Senior Managing Director - Blackstone Life SciencesMore on OIS@SECO 2020:https://ois.net/ois-seco-2020

In this episode of the OIS Podcast we get to hear another panel discussion from the last OIS@AAO meeting in San Francisco. Emmett T. Cunningham Jr., MD, PhD, MPH, led a great discussion about Innovating Around the Globe with 2 international Venture Capitalists and 3 industry executives from Alcon, Santen and Novartis.Participants:Laurent Attias, SVP, Corporate Development Strategy, BD&L and M&A - AlconMichael Keyoung, MD, PhD, Managing Director & Head, North America - CBC GroupGiovanni Mariggi, Partner - MedicxiNaveed Shams, MD, PhD, Head, Global R&D, Chief Scientific Officer, Senior Corporate Officer - SantenJehan Tamboowalla, VP, Head of New Products, Ophthalmology - NovartisModerated By:Emmett T. Cunningham Jr., MD, PhD, MPH, Senior Managing Director - Blackstone Life SciencesJoin us this year at the 12th Annual OIS – November 12, 2020 » Las Vegas, NVhttps://ois.net/12th-annual-ois

In this special episode of the OIS podcast, we have a discussion that took place during the recent OIS@SECO in Atlanta. Summit Co-Chairman, Paul Karpecki, OD, FFAO, set the stage with some staggering figures which led to an insightful conversation between two ODs and two MDs about Collaborative Care models and the benefits to both patients and practices.Participants:Thomas Chester, OD, Clinical Director - Cleveland Eye ClinicElise Kramer, OD, FAAO - Miami Contact Lens InstituteWilliam Trattler, MD, Director of Cornea - Center For Excellence In EyecareWilliam Wiley, MD - Cleveland Eye ClinicModerated By:Paul Karpecki, OD, FAAO, Associate Professor - UPike College of Optometry/Kentucky Eye InstituteMore on OIS@SECO 2020:https://ois.net/ois-seco-2020

Emmett Cunningham talks with Suzana Nahum-Zilberberg about the robust innovation scene in Israel, and how she and co-chair Daphne Haim-Langford, PhD developed the idea for OIS Israel.Register for the next OIS Event at OIS.net

This past week OIS Podcast host, Dr. Ehsan Sadri had the opportunity to chat with J&J Vision’s newly appointed Worldwide President of Surgical, Mr. Warren Foust.  In this episode Warren describes his background leading up to this new position. He also shares his “vision” for the organization moving forward, how they plan to enhance the customer experience and challenges to addressing unmet vision needs.REGISTER for our next ophthalmology conference today – OIS.net

In this episode of the OIS Podcast, Dr. Ehsan Sadri sits down with industry veteran Tom Frinzi to learn about Johnson & Johnson Vision Care’s current innovation efforts, the impact of cuts in reimbursements, growth drivers for the premium channel, and how his team is positioning the company to remain a leader in ophthalmology. And he provides some practical career advice.

Tom Mitro of Aerie Pharmaceuticals opens up to OIS Podcast host Ehsan Sadri, MD, about the company’s key programs, including the Phase II trial of netarsudil ophthalmic solution for treatment of open-angle glaucoma.

Patrick Mooney, head of Novartis’ US eye care business, lays out Novartis’ plans following the spin-out of Alcon and bid to acquire the former Shire ophthalmology franchise from Takeda. Where does Novartis see future growth in eye care? Will ophthalmologists and optometrists see a difference? Is Novartis done acquiring products for a while? 

Avedro Inc. went public on Feb. 14, raising $70 million with its shares pricing at, coincidentally, $14. We talk with Reza Zadno, CEO and president, about the IPO process, which, as you might imagine, she says is as difficult as it looks. We’ll also talk business. Avedro, of course, is a commercial enterprise now, reporting growing sales on its Corneal Crosslinking System that can be used to treat keratoconus, a non-inflammatory eye condition that weakens and misshapes the cornea. What does the future hold for the start-up?

Oculis CEO Riad Sherif, who once worked for Novartis and Alcon, reveals which company he’d invest in following the spin-off of the latter from the former – but mostly about the Switzerland-based start-up’s promising new pipeline for DME, post-surgery inflammation, and dry eye.

With more than $100 million raised in venture capital and three late-stage clinical programs, Oyster Point Pharma is getting a lot done in a short amount of time. In this podcast, CEO and president Jeffrey Nau reveals how the company is working so quickly and ponders what the next major milestone might be. 

After entering the ophthalmology industry “by accident,” Bernhard Günther founded Novaliq in 2004 to pursue therapeutic applications for CyclASol, a novel solution used in drug delivery. While Novaliq pursued other therapeutic applications initially, fate once again brought Günther back into ophthalmology. Today, the company is positioned to deliver two new treatments for dry eye disease. In this podcast we’ll cover the company’s origins, its unusual investor, and its move to the US.

We dip into the gene therapy pool one more time, talking with Jay Duker, MD about Luxturna’s impact on ophthalmology. We also discuss how the acquisitions of Spark and Nightstar are benefiting earlier-stage gene therapy start-ups, including his own Hemera Biosciences.

Together, Roche and Biogen paid over $5.5 billion for gene therapy companies Spark and Nightstar. What does this mean for the emerging technology? Spark, of course, received FDA approval for Luxturna as a treatment for inherited retinal disease. But the drug isn’t Roche’s primary focus. Meanwhile, Nightstar’s clinical-stage products could give Biogen a second shot at a gene therapy portfolio after the company severed ties with AGTC in December. Could Biogen make a move to bulk up its ophthalmology offerings?  

Industry leaders say optometry presents an enormous opportunity for eye care companies.Participants:Joseph Boorady, OD, FAAO, VP, Ocular Surface - Johnson & Johnson VisionRobert Dempsey, Head of Global Ophthalmics Franchise - TakedaDave Gibson, Associate VP, Consumer Eye Care & Customer Development - AllerganAngelo Rago, Global Head, Ophthalmic Diagnostics - Carl Zeiss MeditecCalvin Roberts, MD, SVP, Chief Medical Officer - Bausch + Lomb Moderated By:Emmett T. Cunningham Jr., MD, PhD, MPH, Sr. Managing Director - Blackstone Life Sciences

We visit again with James Thimons, OD, FAA, co-chair of OIS@SECO, the newest member of the OIS family. OIS@SECO convened last week in New Orleans, drawing more than 200 optometrists, entrepreneurs, and industry members. In this interview, Dr. Thimons, clinical director of Ophthalmic Consultants of Connecticut, walks us through the day. We also ask the dry eye expert his take on the recent fund-raising success of Oyster Pharmaceuticals, developer of a nasal spray that might help relieve the pain of that persistent condition.

Former Aerie CMO Brian Levy, OD, was settling down for a quieter life in Florida when he came upon OcuNexus, a biopharmaceutical company utilizing a novel mechanism of action called “Gap Junction Channel Modulation” to develop treatments for the front and back of the eye. Levy saw the opportunity to create a biopharma capable of devising new therapies inside and outside of ophthalmology.

Twenty five years ago, Michael Freeman collaborated with his father and brothers to create the first video technology that could transmit via cellular technology. As important an achievement as that might be, Freeman is developing an augmented reality device that could have an even greater impact on people who have lost their vision to Macular Degeneration. Once again, Freeman and his brothers have their father’s leadership to thank.

Paul Karpecki thought his odds were pretty good at the start of his career, but an early setback put him on a path that’s made him one of the most successful optometrists in the country. In this interview, Karpecki recounts his path to optometry and looks forward to how technology will change how he and other optometrists care for their patients. He also explains why he agreed to serve as a co-chair of the February 21 OIS@SECO.

Eye care innovator extraordinaire Mark Blumenkranz joins the podcast to preview the April 8 Forum on Laser-Based Imaging workshop. In this interview, Blumenkranz explains why eye care professionals of all types – ophthalmologists and optometrists – should plan on attending. We also talk about one of the more recent investments by Blumenkranz’s venture firm, Lagunitas Biosciences. Go to this link for more information about the workshop.

Vance Thompson Vision’s Justin Schweitzer, OD, will speak next month at the February 21 OIS@SECO. In this podcast, Dr. Schweitzer shares his insights on patient responses to new treatments for dry eye, glaucoma, and other conditions ­– and a whole lot more. He also is excited by new tools to be added to optometrists’ armamentarium. What brought him into optometry? What has him most excited about the future? 

In this encore OIS Podcast, well-known Dry Eye Coach discusses some of the strategies she’ll be sharing next month at OIS@SECO. Dr. Hauser will help lead off next month’s program at OIS@SECO. In this encore OIS Podcast, Dr. Hauser shares her insights on new dry eye treatments and offers advice for building an eye care practice through social media. 

Susan Orr, recently named CEO of Notal Vision, lays out an ambitious plan for the “16-year-old start-up” that promises better treatment and tracking for patients with age-related macular degeneration. Can Notal Vision create an effective home-based OCT scanner? Orr also walks us through a career that bridges optometry and large corporations. How is she preparing for the CEO role?

OIS Podcast visits with Eric Donnenfeld, MD, to review the field of innovative dry eye companies. We discuss the advances in drugs and devices, and Dr. Donnenfeld shares how new treatments are impacting ophthalmology, optometry, and combined practices. Few know the dry eye space as well.

Chris Wroten, OD, left a chemical engineering career to pursue his early love of optometry. This path followed a few detours and disasters (of the natural kind), but he credits the ophthalmology community for seeing him through some challenging times. Dr. Wroten, who is helping to organize the upcoming <a href="https://ois.net/ois-seco-2019/">OIS@SECO</a> in New Orleans, sees smooth roads ahead for innovation in eye care.

Steven Silverstein, MD, visits with the podcast to explain how extensively he uses Light Induced Visual-Response testing in his daily practice. We spoke with Dr. Silverstein prior to a talk he gave at this year’s AAO meeting. He explains how the test delivers important insights on patients battling several eye conditions including glaucoma, diabetic macular edema, and diabetic retinopathy. We also talk about his role in local politics, fluoridation, and how he got backstage with KISS.

First, thanks to everyone who has helped make the OIS Podcast such a success. We at Healthegy – the producer of the OIS Podcast and events – are grateful for your support. In this week’s episode, we’re visited again by Michael Abramoff, MD, founder and CEO of IDx, the first company to obtain FDA approval for an AI diagnostic tool. In this interview, Dr. Abramoff explains how IDx-DR, an autonomous AI diagnostic for diabetic retinopathy, worked its way through the FDA. He also shares the process he used to raise $33 million from a syndicate of high-powered investors including 8VC, Optum Ventures, Alpha Edison, and Heritage Provider Network. What’s the next step for IDx? Is it an IPO?

An OIS@Mars probably isn’t in the cards, but the Red Planet remains a tight focus of ophthalmic innovators like Bob Main of Web Vision Technologies. In this podcast, Main explains why he’s looking for ophthalmic companies with The Right Stuff for space travel.Web Vision Technologies is working closely with the National Aeronautical Space Administration (NASA) to develop an "All-in-One" vision testing (diagnostic) device that can be deployed on spacecraft for conducting comprehensive vision testing and evaluation, and to guide medical interventions of astronauts experiencing vision problems on future long-duration, deep space missions. 

Aldeyra CEO and president Todd Brady shares the podcast mike with Dave McMullin, the former Shire executive who recently joined as senior vice president of corporate development and strategy. Together, the pair discuss the company’s positive Phase II test results for topical ocular reproxalap in patients with dry eye disease. They also speak about Aldeyra’s promising pipeline.

In this podcast, CEO Franziska Ullrich explains how start-up Ophthorobotics is working to create a robotic system that can deliver intravitreal injections, freeing up physicians to work on other procedures. Ullrich discusses the system’s origins, its clinical path, and what plans are for the future. Ullrich will also present the company’s story at the October 25 OIS@AAO.

Eyedaptic president and founder Jay Cormier tells OIS Podcast about his company’s augmented reality visual aid for people with late-stage age-related macular degeneration, which it expects to start beta testing soon. Watch his presentation at OIS Retina in Vancouver here.

Founder and CEO Joel Wishkovsky created Simple Contacts’ phone-based app to save contact lens wearers time and money when they need a new supply of lenses but not a new prescription. Ophthalmologists are funding the company and conducting the remote examinations. But the firm isn’t seen favorably by optometrists, who stand to lose a steady stream of business.

In this podcast, James Thimons, OD, delivers a comprehensive state of innovation in the treatment of eye disease. We recorded this interview in August immediately following the National Glaucoma Society meeting on Cape Cod. Thimons discusses the impact of artificial intelligence, MIGS, extensive pressure monitoring, and the potential of a device that should be familiar to OIS Podcast listeners. He also explains the potential of the Ocular Response Analyzer and the ICARE Home Tonometer in the monitoring, diagnosis, and treatment of glaucoma. 721903

Chris Calcaterra, COO of Glaukos, revisits the company’s recent good fortune at the FDA, which approved its second generation iStent inject. What’s next for Glaukos? Calcaterra walks OIS Podcast listeners through the company’s “Five in Five” pipeline. In a follow up to the interview, Calcaterra also reacts to Alcon’s decision to recall CyPass. How will this impact Glaukos? Does he have any concerns?

Louis Pasquale, MD, introduces us to the promising results of Eyenovia’s trial of its Microdrops latanoprost delivery platform. He also talks glaucoma. Is there an unexplored cause? And what promise does telemedicine hold for ophthalmology?

Peter Menziuso, president, North America Vision Care, Johnson & Johnson Vision, discusses J&J’s efforts to lobby against any significant changes to the contact lens rule, saying patients are best served by obtaining prescriptions through eye care professionals. He explains J&J’s acquisition of online service, Sightbox.

REGENXBIO founding CEO Ken Mills reviews the company’s recent positive Phase I results for RGX-314, a potentially game-changing gene therapy for wet AMD. Mills also shares the responsibility he feels leading a pioneer in the blockbuster gene therapy field.

Verana Health, once known as DigiSight, has been working to make AAO’s EHR database available to commercial partners. Now, the company plans to expand that model in healthcare. In this week’s OIS Podcast, Doug Foster, the new chief strategy officer, explains how the company plans to use the AAO relationship as a template to work with other societies. He also talks about Verana’s new CEO Miki Kapoor (heard on this Breaking Health Podcast) and the new $30 million round of financing led by GV, the venture arm of Alphabet Inc.

OIS Podcast Host Tom Salemi Speaks with Investors Greg Grunberg, MD, and Firas Rihhal, MD, as well as OIS Contributors Richard Mark Kirkner and Bérénice Magistretti about some of the key takeaways for investors, physicians and patients.

This week the OIS Podcast skims the ocular surface with two interviews. First, we talk with Amy Gallant Sullivan, executive director of the Tear Film and Ocular Surface Society (TFOS), about her organization’s work in raising awareness about ocular surface disease and dry eye. TFOS and the Alliance for Eye and Vision Research sponsored a congressional briefing on dry eye in Washington, DC, last week. Then, Purdue University researcher Chi Hwan Lee, PhD, explains why Google and Alcon inspired him and his team to develop the glucose-sensing contact lens. What’s next for the early stage project?

With Oyster Point Pharma announcing results from the Phase IIb PEARL study, company president and CEO Jeffrey Nau, PhD, talks with OIS Podcast about what the findings mean for OC-02, a nicotinic acetylcholine receptor agonist the company is developing to treat the signs and symptoms of dry eye disease. The study met both primary endpoints by showing a statistically significant improvement in signs and symptoms compared with control. Top-line data from the study will be presented this weekend at the American-European Congress of Ophthalmic Surgery Summer Symposium in Deer Valley, UT. OC-02 is delivered as a nasal spray and stimulates the trigeminal parasympathetic pathway to activate the glands responsible for producing the eye’s natural tear film.

In this podcast, John Berdahl, MD, of Vance Thompson Vision highlights the role mentors have played throughout his career including guiding him into ophthalmology and convincing him to start a company. He also speaks to why game-changing innovation is more difficult to do.

Ask renowned vitreoretinal surgeon and inventor Steve Charles, MD, if he considers himself a surgeon or engineer first and he'll answer - both. In this OIS Podcast, Dr. Charles says the terms "inventor" and "innovator" aren't job titles. Innovation and inventing are what you get when insightful people commit themselves to a lifetime of learning in engineering and medicine. Dr. Charles gives his view of the future of innovation in the US. Here's a hint. You won't need to wear shades.

The last time we connected with Sean Ianchulev, MD, MPH, he shared Transcend's ultimately winning story. Now, he's the CEO and CMO of Eyenovia, a four-year-old company that's developing a line of therapeutics for Glaucoma, Dry Eye, Mydriasis, and Myopia. The company says its high-precision microdosing can deliver smaller doses with greater effect by uniformly coating the corneal surface rather than the conjunctiva to reduce collateral tissue exposure and focus on the cornea where 80% of intraocular drug penetration occurs. By reformulating generic compounds like latanaprost into microdose versions, Eyenovia is advancing its two lead assets for glaucoma and mydriasis into Phase III clinical programs and preparing registration studies for a third OTC product for dry eye. Eyenovia is expected to complete all three development programs through registration by 2020. The company's delivery device also is able to track dosages, giving patients, physicians, and caregivers the ability to closely track when these therapies are delivered.

Hear the latest from OIS events as the OIS Podcast connects with Tom Frinzi and Joseph Boorady, the new leadership at Johnson & Johnson Vision. Next, CEO Jeffrey Nau introduces Oyster Point to OIS while Rob Thornhill, CEO of Tear Film Innovations, explains his company's treatment for Meibomian Gland Disorder.

Nicox has had quite a year, bringing two new ophthalmology projects to the market through partnerships with Bausch + Lomb and Eyevance Pharmaceuticals. So what's next for the global company? CEO Michele Garufi provides answers. James V. Mazzo, global president for Carl Zeiss Meditec's Strategic Business Unit Ophthalmic Devices, sits down with us at OIS@ASCRS to talk about his three years at the company and what the future might bring.

The OIS Podcast returns with a double feature. Avedro CEO Reza Zadno talks about the company's latest $25 million round. Also, Bill Meury, CCO of Allergan, visits at OIS@ASCRS to talk about the company's appetite for acquiring innovation. You can watch our April 12 interview with Dr. Zadno at OIS@ASCRS here. You can also watch the podcast interview with Bill Meury, which was conducted at OIS@ASCRS.

Whitney Hauser, OD, has built a very visible brand as the Dry Eye Coach. With a website, podcasts, and sizable following on social media, she is building a platform that can help promote new treatments and fellow eye care providers. In this podcast, Dr. Hauser discusses new technology that can help treat patients. But she also shares how social media can help build and maintain a practice.

Al Waterhouse, President and COO of AcuFocus, tells the OIS Podcast why the company opted to sell its former flagship product to focus on IOLs. In this discussion, he discusses some of the headwinds in the corneal inlay market. Waterhouse also shares a few details on structure of the sale, which makes AcuFocus in interested partner in Kamra's future success.

SightLife Surgical in 2016 spun out of the well-known SightLife eye bank, capitalized by Flying L Partners. Two years later, Monty Montoya, president and CEO, explains what the start-up is doing to build a new market in cornea products. In this podcast, Montoya discusses the Kamra acquisition and hints at news he'll be releasing at OIS@ASCRS.

The last time OIS Podcast talked with David Muller, he was leaving Avedro to start a new company. Two years later, Allotex has raised capital from a strategic investor and is preparing to enter clinical trials in Europe.

Sue Washer, AGTC president and CEO, has joined the board of directors of the Biotechnology Innovation Organization (BIO). In this podcast, she talks about how she'll fulfill her duties for the biotech advocacy organization.

Robert Dempsey, head of Shire's global ophthalmics franchise, will be a headliner at next week's OIS Launch Dry Eye Innovation Dinner held during the SECO 2018 meeting. In this podcast, Dempsey discusses the importance optometrists are playing in Shire's strategy

OIS - the Ophthalmology Innovation Summit - is introducing a new OIS Launch program to raise awareness and inform early adopters on recently launched and soon to be approved therapies. The inaugural OIS Launch is an invitation-only dinner program led by Paul Karpecki, OD, Joe Boorady, OD, and Emmett Cunningham, MD, who have developed a program to feature select companies with emerging dry eye therapies - followed by a panel of thought leaders to discuss and debate the benefits and advantages of each. For details go to https://ois.net/ois-launch-2018/.

New CEO Antony Mattessich says Ocular Therapeutix has learned its mistakes after receiving two CRLs from the FDA. With new leadership and a clear vision, the company is ready to push forward as a full-fledged biopharmaceutical company.

A veteran of bioelectronic medicine, Khalid Ishaque joined Pixium Vision four years ago after recognizing the promise of using implantable devices to restore vision. Today, the company is developing not one - but two - technologies that could help restore sight.

Apple made headlines with a promise to spend repatriated dollars on R&D in the US. In this week’s podcast we talk with three Wall Street analysts to understand what we can expect to see from pharma and Medtech companies following the monster acquisitions of Juno, Kite et al. What ophthalmology companies might be acquisition targets? Will Medtech companies follow suit?

Cedric Francois, president and CEO, discusses his debut performance at JP Morgan in which he laid out the company’s plans for a Phase III trial of APL-2, the promising treatment for geographic atrophy. Francois shared the details of the trial, talked about going public, and shared one of the least recognized – but most important – challenges facing biopharma companies.

Roger Longman, CEO of Real Endpoints, a firm assisting pharma companies with their pricing strategies, discusses the state of the value-based pricing market while lending some insights on what specialty drug companies like Spark can do to get payers on board with higher prices.

Oyster Point Pharma CEO Jeff Nau sheds some light on the new dry eye start-up, which is tapping much of the leadership and investment team that made Oculeve successful. He also talks about his own experiences leading high-profile clinical programs at Ophthotech and Genentech. What lessons will he bring into his new CEO role?

Michael Abramoff, MD, PhD, president, director, and co-founder of IDx, tells how the start-up is using artificial intelligence to better diagnose diabetic retinopathy. The company hopes to get FDA approval of its IDx-DR system.

In part one of a two-part podcast, OIS co-chair and Clarus Funds managing director Emmett Cunningham, Jr., MD, PhD, MPH, delivers a 360-degree review of ophthalmology’s more promising pipelines. To download a copy of an extended version of the Year in Review report delivered at OIS@AAO click here.

In part one of a two-part podcast, OIS co-chair and Clarus Funds managing director Emmett Cunningham, Jr., MD, delivers a 360-degree review of ophthalmology’s more promising pipelines.

In interviews at OIS@AAO, we talk with Robert Dempsey, global head of Shire’s ophthalmic business, about the international launch of Xiidra. Joseph Boorady, CEO and president of TearScience, lays out the company’s plans since being acquired by Johnson & Johnson Vision. Finally, Tom Gadek, president and CEO of TearSolutions, explains how he’s hoping to score another winning dry eye treatment with a start-up.

Brent Saunders, president, CEO, and chairman of global leader Allergan, sits down at OIS@AAO to discuss what impact the pending loss of the Restasis patent could have on the company. He also rejects talk of Allergan breaking off its ophthalmology business, saying the company is in the sector to stay.

Eric Donnenfeld, MD, founding partner of Ophthalmology Consultants of Long Island, explains how his practice will use a capital infusion from growth equity firm Blue Sea Capital. Dr. Donnenfeld also opines on the growing cooperation - and competition - between ophthalmologists and optometrists. Plus, he explains how he uses CheckedUp to engage his patients.

OIS co-chair Emmett T. Cunningham Jr., MD, PhD, MPH, talks about OIS’ evolution over nearly a decade of meetings. The addition of Breakfast Breakout Sessions and Master Classes has opened opportunities for speakers and attendees. Dr. Cunningham, a partner at Clarus, also walks us through the agenda of next week’s OIS@AAO in New Orleans. This year’s agenda includes several new topics and formats as well as the return of a familiar face on stage.

Aerie Pharmaceuticals scored an impressive win at the recent FDA advisory panel, getting a thumbs up for the approval of Rhopressa. In this interview, CEO Vince Anido explains how Aerie plans to move forward with its lead glaucoma product. He also tells how its new drug-delivery technology will fit into its plans. In addition, we get an update on the late-stage trials of Roclatan.

Ophthalmology companies have had a difficult time targeting AMD lately. Newcomer Gemini Therapeutics is bringing a “multimodal approach” to identify new targets in the complement system, with an eye toward developing specific treatments for patients with connected genetic codes. CEO, president, and co-founder James McLaughlin explains how Gemini hopes to advance the war against these dreadful diseases.

CEO Paul Chaney details the company’s plans to move forward with $11 million in new capital. He also recounts how his unplanned entry into ophthalmology led him to appreciate how special the specialty truly is. Chaney also explains why PanOptica’s pursuit of an eye-drop-based treatment for AMD and DR is personal.

With $3 million to invest in first-time funds, impact investor ExSight Capital built a promising and productive portfolio that included gene therapy company RetroSense. Now, ExSight co-founder and partner Firas M. Rahhal, MD, says the firm is planning to raise a much larger fund that could elevate its standing as a seed-stage investor in ophthalmology companies.

Pravin Dugel, MD, managing partner, Retinal Consultants of Arizona, delivers a frank overview of the pipeline of experimental retinal drugs. The next year could be critical for retinal disease as combination therapies and other products push through late-stage clinical trials. What technologies show the most promise? What advances have surprised even him?

Christy Shaffer, PhD, general partner at Hatteras Venture Partners, didn’t have a career map that led her into the corner office at Inspire Pharmaceuticals or into the partnership at Hatteras Venture Partners. But the clinical scientist grew to succeed in both roles. Dr. Shaffer led Inspire when the company conceived and then built out its ophthalmology program, a business that trained many of today’s ophthalmology leaders. That experience still serves her today as she funds entrepreneurs and start-ups inside and outside of ophthalmology.

Accomplished ophthalmologist Mark Blumenkranz, MD, moved early into the Digital Health space by co-founding Digisight, one of the more advanced efforts in ophthalmology. Six years, later, Dr. Blumenkranz still sees enormous opportunity so he’s working with the FDA and top clinical societies to hold a one-day workshop for physicians, investors, and entrepreneurs interested in learning how Digital Health fits into ophthalmology.

In 2011, Cal Roberts, MD, got an unexpected call from Brent Saunders, then head of Bausch & Lomb. Saunders asked if Dr. Roberts would trade a thriving ophthalmology practice to serve as chief medical officer at the eye care giant. Today, Dr. Roberts is thrilled with the decision, and other ophthalmology companies are following the example, bringing on practicing physicians as CMOs. But what were Dr. Roberts’ concerns? And why did he decide to take the leap? “It’s difficult and it’s sometimes more difficult than someone coming in realizes,” he says.

M. Francesca Cordeiro, MD, PhD, professor, UCL and Imperial College London, Western Eye Hospital London, shares details of the institute’s detection of apoptosing retinal cells (DARC) scan – which employs a new retinal biomarker. The DARC system, which will undergo further trials, could allow for earlier detection of retinal disease in patients, as at least 30% to 50% of ganglion cells may be lost before vision is damaged. This test could be used to hone clinical trial endpoints of ophthalmology drugs, but it also may be used to detect neurological disease such as Parkinson’s and dementia.

Charles Semba, MD, is one of the more recognized and accomplished figures in development of new ophthalmology treatments. He has played integral roles in the development of Lucentis, Xiidra, and more recently Forsight IV’s drug delivery technology. Now the chief medical officer at Graybug Vision, Dr. Semba is working to develop a technology that could significantly reduce the number of injections needed to deliver drugs to the back and front of the eye. But how did Dr. Semba, who had been a world renowned vascular specialist, run out such a string of successes in ophthalmology? And what is the biggest regret of his accomplished career?

OIS@ASRS co-chairs Emmett Cunningham Jr., MD, Mark S. Humayun, MD, PhD, and John Pollack, MD, took a few minutes to share their thoughts on the second OIS@ASRS. Dr. Humayun, the outgoing ASRS president, shares details on his next undertaking – finding a way to measure the value of vision protection. Meanwhile, Dr. Pollack highlights one of his priorities after taking over as ASRS president.

OIS Co-chair Emmett T. Cunningham Jr., MD, PhD, MPH, managing director, Clarus Funds, walks us through the agenda of Thursday’s OIS@ASRS. What areas of retina will dominate the headlines for the next 12 months?

Last week, Johnson & Johnson announced plans to acquire TearScience, maker of a line of products capable of diagnosing and treating Meibomian gland dysfunction, a leading cause of Dry Eye. Ashley McEvoy , Company Group Chairman for Johnson & Johnson Vision, explains where TearScience will fit into J&J if the deal is completed and what the global giant’s plans for additional Dry Eye treatments may be.

Allegro Ophthalmics expects to deliver some positive news about its Phase II DEL MAR trial that is evaluating the safety and efficacy of Luminate as an adjunctive therapy with anti-VEGFs in patients with diabetic macular edema (DME). Could the news put the company in a position for an initial public offering?

In two recent interviews, Elizabeth Yeu, MD, Virginia Eye Consultants, and Richard Lewis, MD, Sacramento Eye Consultants share how innovation is changing how they treat patients. Reimbursement, marketing and the future of new tech also are discussed.

In this OIS Podcast, David Alpern, partner at Varsity Healthcare Partners, and Brent Wilde, president of Minnesota Eye Consultants, offer complimentary perspectives on Private Equity’s impact on ophthalmology practices.

Jerry St. Peter, VP & head, ophthalmic business, says the ophthalmology newcomer is making great progress in building a broad pipeline to treat eye disease including dry eye and ocular pain. In this interview he reviews several acquisitions and partnerships the company has made over the past 24 months.

Laurent Attias, head, strategy, BD&L and M&A, reports on progress on Alcon’s project with Google and its advancing glaucoma portfolio. Attias says Alcon is “open for business” and continuing to advance innovative ideas in ophthalmology.

After capturing lighting in a bottle with Oculeve, Ali Behbahani, MD, partner of New Enterprise Associates, recalls the experience with the Dry Eye start-up and lays out his plans for investing in future ophthalmology start-ups.

Max G. Ostermeier, MBA, co-founder and general manager of Implandata Ophthalmic Products GmbH, charts a course for the company after securing CE mark for its EYEMATE eye pressure measurement system for continuous measurement of IOL in patients with glaucoma.

Mynosys Cellular Devices CEO and president John Hendrick lays out his company’s plan to roll out Zepto in the US. The firm has reported strong demand in OUS markets, and Hendrick anticipates it will upend the capsulotomy market.

Eric Donnenfeld, MD, founding partner of OCLI, shares how his practice is incorporating new diagnostics and treatments. “I spend less time diagnosing the disease and it enables me to spend more time talking to the patients about therapies,” Dr. Donnenfeld says. He also praises Shire and Allergan for their effective marketing.

In this interview, Tom Mitro, COO of Aerie Pharmaceuticals, says new hires brought on to prepare for likely commercial sale of Rhopressa bring new life and energy into a company hitting its stride. He also provides to OIS@ASCRS an update on the firm’s glaucoma pipeline.

Ludwin Monz, PhD, President and CEO of Carl Zeiss Meditec explains why the ophthalmology leader brought in new senior leadership. He also reviews the company’s recent product approvals and gives an assessment of the “amazing possibilities” within diagnostics.

Now that Shire’s Xiidra claims a 20% market share, find out how it’s impacting the practice. Alice Epitropoulos, MD, of Ophthalmic Surgeons & Consultants of Ohio, sat down with OIS-TV to explain how Shire, TrueTear, and other advances are impacting her Dry Eye patients.

LensGen CEO Ram Rao discusses his company’s $21 million Series A and the increased interest in presbyopia.

Emmett Cunningham, MD, Gil Kliman, MD, and Bill Link, PhD, co-chairs of OIS, talk about device funding, myopia, and the Masters of the Industry following a successful OIS@ASCRS.

Gil Kliman, managing director at InterWest Partners, reviews his role at the upcoming OIS@ASCRS, including an overview of anterior segment innovation and a discussion on lower myopia.

Longtime eye bank executive David Korroch, chief executive officer, Lions Medical Eye Bank, explains how eye banks have worked hard to meet – and even exceed – the demand for donated tissue. Korroch is the winner of this year’s Leonard Heise Award.

Mark S. Blumenkranz, MD, H. J. Smead Professor of Ophthalmology, Emeritus, delivers his State of Innovation address. You can guess what his assessment is, but we’ll give you a hint. It involves cool lasers.

OIS Co-Chair William J. Link, PhD walks us through OIS@ASCRS’ May 4 agenda, which takes place in LA. Link also explains why he Andy Corley and Richard Lindstrom, MD, formed Flying L Partners. Hear about the firm’s most recent investment.

From his clinic in South Dakota, Vance Thompson has served as an investigator in over 60 clinical trials. Thompson taps this experience to shed some light on new innovations being brought forth by Zeiss, Avedro, Allergan, and RxSight. He also offers a few insights on new advances coming down the pike.

In 2015, three patients who had a stem cell mixture injected in their eyes were severely injured. To try to prevent this from happening again, their treating physicians reached out to the FDA and clinical societies, and ultimately they wrote a paper for the New England Journal of Medicine to warn others about the dangers of these so-called treatments. In this podcast, one of the co-authors, Thomas Albini, MD, of the Bascom Palmer Eye Institute, talks about the cases and the surgeons’ decision to try to prevent other dangerous treatments.

Newly appointed President and CEO Nancy Lurker explains why she took over as CEO and President at pSivida and gives details on the company’s early clinical testing results in the recurrence of uveitis. Lurker hits upon filing for regulatory approval filings, building a sale team and operating a drug company at a time of political uncertainty.

Last month, Minnesota Eye Consultants announced it was working with private equity investor Waud Capital to create an entity that could build a national eye care provider. In part two of our interview with MEC founder Richard Lindstrom, MD, we discuss the impact similar consolidations could have on the sector.

Consolidation is coming to ophthalmology. Last month, Minnesota Eye Consultants agreed to partner with a private equity group to expand beyond the Twin Cities. In the first of a two-part podcast, founder Richard Lindstrom, MD, explains why the deal was done.

Cedric Francois, co-founder, CEO, and president of Apellis delivers an update on his start-up’s promising complement therapies. He also shares why he joined other Biotech CEOs and VCs in speaking against the proposed immigration restrictions.

On February 28, the National Eye Institute will host a webinar to introduce its 3D Retina Organoid Challenge. Its objective is simple: use $1 million in prize money to encourage researchers from multiple disciplines to create a critical tool for retinal research. The NEI’s Jessica Mazerik and Steve Becker share the details, which can also be found here.

Ophthalmology CEO turned VC Abbie Celniker, now a partner at Third Rock Ventures, discusses her role at the firm and reveals how it will invest its new $616 million fund.

With Novartis’ acquisition of Encore Vision setting the standard, CEO Jim McCollum and CSO Jerry Horn, MD, tell the tale of Presbyopia Therapies, a small start-up that is working to develop “lifestyle” eye drops that can help presbyopes read without assistance.

Frederic Guerard, head of Novartis’ ophthalmology franchise, explains why the global giant was the last strategic standing in the competitive bidding to acquire the promising, but very early stage, start-up. Novartis will resume testing of the new presbyopia-correcting ophthalmic solution, now dubbed UNR-844.

The threat of Medicare clamping down on drug prices has never loomed larger. Sanford Bernstein’s Ronny Gal and Liav Abraham of Citi gauge the risk and explain how ophthalmology drug companies might be impacted.

Christian Roesky, PhD, joins the OIS Podcast to explain why he became the new CEO and managing director of Novaliq GmbH, a specialty pharma company with a novel drug delivery platform technology that can make drugs more effective in treating ophthalmic disorders. He also delves into the company’s positive Phase II evaluating CyclASol in 207 patients with moderate-to-severe dry eye disease.

EyeGate CEO Stephen From reports positive results of Phase Ia/IIb trials of EGP-437, regulatory progress for its Ocular bandage gel, and potential fundraising plans.

KOLs, CEOs, and analysts say Ophthotech’s disappointing Fovista trials alter the landscape for companies developing new treatments for wet AMD. And all agree, the biggest losers in all of this are patients suffering from the disease.

Three-year-old TearSolutions hopes to pen a strong sequel to SARCode’s successful tale of a start-up developing the next new treatment for Dry Eye Disease. Tom Gadek, co-founder of SARCode, developer of lifitegrast (now Shire’s potential blockbuster Xiidra), takes over the company as it begins courting partners and investors.

Carl Zeiss Meditec continues to add top talent. Andrew Chang, who managed US sales at B&L, joins the growing group bringing him together with Unit Head Jim Mazzo.

This has been a busy year for Thomas Frinzi, senior vice president of Abbott’s vision business. He took the helm of Abbott Medical Optics in January. In July, the FDA approved the company’s promising new Tecnis Symfony IOL. Then Johnson & Johnson agreed to pay $4 billion to acquire the vision device company in September. What’s next?

The election of Donald Trump had an immediate impact on our OIS Index. OIS writers and editors dig deeper, discussing what the long-term impact could be on drug prices, regulation and the ophthalmology’s bottom line?

Ophthalmology veteran Jim Mazzo has led companies of every size. Hear how those experiences are guiding him in his new post at Zeiss.

Gavin S. Herbert recalls what it took to make Allergan a success and how he helped build a Medtech industry in Southern California.

After being honored by OIS last week in Chicago with an OIS Innovator Award, David Pyott, former Allergan CEO, sits down with OIS-TV to discuss rebuilding Allergan, fending off Valeant’s acquisition bid, and how he feels about the acquisition by Actavis. He also reviews the work he’s doing with start-ups and global charities.

This OIS Podcast brings a bit of OIS@AAO to your laptop and smartphone. Hear from a few of the leaders in ophthalmology including executives from Allegro Ophthalmics, Avedro, LacriScience, Ocular Therapeutics, Opthea, and Sightline Surgical.

OIS has partnered with Michael Lachman of EyeQ Research to create a vital new stock index of ophthalmology companies. This new tool will enable us to deliver broader insights and stronger analysis of our exciting sector.

Emmett T. Cunningham Jr., MD, PhD, MPH, partner at Clarus, runs through the revamped agenda of OIS@AAO. Go to OIS.net to view the agenda and to register.

This month, a surgeon performed ophthalmology’s first robot-assisted surgery – a membrane peel. Prof. Marc de Smet, chief medical officer of Preceyes, a Dutch start-up shares the company’s history and plans for the future.

Ashley McEvoy, group chairman of J&J’s Vision Group, says the combination of consumer and surgical businesses will create a powerful new force in ophthalmology.

Copenhagen was the epicenter of the ophthalmology last week as several clinical meetings including ESCRS, EuRetina, and EuCornea convened in the city. OIS Podcast reports from the hallways, meeting spaces, and exhibition floor.

Shire scored a huge win this summer by securing FDA approval of Xiidra. Hear from three principals of SARcode Bioscience, the start-up that discovered the Dry Eye treatment – then known as lifitegrast.

OIS Podcast hit the century mark. Rather than offer a retrospective piece, we hope you enjoy this thoughtful look forward as we ask physicians, executives, investors, and others what is to come in ophthalmology innovation.

ReVision Optics built it – a corneal inlay capable of correcting presbyopia. The FDA approved it sooner than expected. Now the company needs to build it into a successful private-pay business.

Live from the floor of OIS@ASRS: Co-chair Bill Link on what made the day work so well. The marriage of OIS with ASRS started strong. Hear ophthalmology veteran Bill Link on why the back of the eye is an enormous opportunity for companies, investors, and physicians.

Meet the newest Master of the Industry. Jim Mazzo, who has led divisions, spin-outs, and start-ups, now leads what looks to be a new leader in ophthalmology. Hear how Mazzo views this new opportunity for Zeiss and himself.

Clearside CEO Dan White says the days when ophthalmology IPO candidates could do no wrong are over. Still, the company staged a successful IPO to help further development of its SCS microinjector technology.

Allegro Ophthalmics’ executive team boasts a successful pedigree that began with starting ISTA and taking it public. Now, Vicken Karageozian, MD, president and CMO, says the company is six months away from receiving results from Phase II trials. Hear how the firm has advanced this promising new drug without venture capital.

Robert Dempsey joined Shire to build a new ophthalmology unit. Until now, the division had been mostly theoretical with no products to sell. Now, the brand building is over. Shire officially has entered the ophthalmology sector with the launch of its potential blockbuster, Xiidra. Hear what’s next for the Dry Eye treatment and what else we can expect to see from Shire’s pipeline.

Over two decades ago, Mark Humayun - who will co-chair our upcoming OIS@ASRS - helped launch a “moonshot” that would eventually restore vision for retinitis pigmentosa patients. In this podcast we discuss what drives him and what’s next for ophthalmology.

Pfizer. Allergan. Valeant. Bausch & Lomb. The ophthalmology sector is rich in big deals that happened, didn’t happen, and could happen. How does the sector – and the market overall – look to analysts?

Steven Vold, MD, sees huge advances in MIGs treatment, drug delivery and new neuroprotective compounds that could help treat glaucoma and perfect vision.

Once a VC, Todd Barry decided to assume the CEO and president post of Aldeyra, a start-up with a promising – and potentially far-reaching – technology for treating ocular and other diseases.

Dr. Ludwin Monz, president and CEO of Carl Zeiss Meditec AG, shares how his company’s long history in ophthalmology helps it pave a path for new markets and technologies.

Bausch & Lomb’s chief medical officer Calvin Roberts, MD, still thinks like a doc when he’s helping to steer the company’s strategy. Hear how he sees B&L making life simpler for ophthalmologists in the near future.

Robert Dempsey, vice president of ophthalmics at Shire, was charged with building a brand in ophthalmology with no new drugs. Two years later, Shire has – in the words of one physician – one of “the best kept secrets” in eye care. Dempsey explains how Shire came to build something from nothing.

Deals sometime collapse, but they usually don’t get hit with a smart bomb from the Department of Treasury. Allergan, newly single following the break up with Pfizer, is looking to build a business in ophthalmology. Bill Meury, the newly named chief commercial officer of Allergan, talks about the non-Pfizer deal, Allergan’s ophthalmology pipeline and where the acquisitive company will be looking for the next deal.

The fifth OIS@ASCRS delivered highlights on diagnostics, glaucoma devices, and What The Future of ophthalmology might bring. OIS Podcasts will provide a quick review of the day for those who couldn’t make it (or simply had overstuffed their meeting calendar in New Orleans).

Graybug interim CEO Jeff Cleland shares details on the company’s $44.5 million Series B. Cleland gives a report on investor appetite for ophthalmology companies. He also explains how the firm would use the capital to shift its approach from a drug delivery platform technology company to a drug maker.

Sun Pharma, the fifth largest pharma company in the US, targeted ophthalmology as one of the first planks in its new branded pharma business. Hear ophthalmology veteran Jerry St. Peter explain how Sun Ophthalmics hopes to build a new team in ophthalmology.

The FDA approved Avedro’s New Drug Application for its riboflavin ophthalmic solution/KXL System (corneal cross-linking for the treatment of keratoconus and corneal ectasia following refractive surgery). OIS Co-chair Gil Kliman, an investor in Avedro, lays out the company’s next plans.

The near merger between Pfizer and Allergan clearly was financially motivated. But the deal promised to bring Pfizer’s firepower to ophthalmology. What does the annulment of the deal mean for our sector?

The complement system is a promising target for drugs being developed to treat macular degeneration. But success has been elusive. A leading KOL and two CEOs explain what the future of the field may be.

Following his successful exit from WaveTec, Tom Frinzi joined Abbott as a senior vice president and head of AMO. In this exclusive interview with OIS, Frinzi shares his motivations and what he’d like to see AMO become.

Clinical trials of complement inhibitors recently have produced some disappointing results, but Apellis remains committed to demonstrating its own inhibitor can help bring relief to people battling geographic atrophy and AMD.

Glaucoma specialist Dr. Richard Lewis says glaucoma was once the “boring step sister” of the ophthalmology world. But now the chief medical officer of Aerie says the rise in devices and drugs has made glaucoma one of the coolest kids in ophthalmology’s school yard.

CEO Wolfgang Tolle joined VisionCare last year to move the company into the commercial stage. Now with long-term data and reimbursement in place, the firm is making a strong commercial push.

Jeff Heier, MD, is the Director of the Vitreoretinal Service and the Director of Retina Research at Ophthalmic Consultants of Boston (OCB) gives an update from the Angiogenesis conference about the advancing anti-angiopoietin programs.

Glaucoma once might have been a boring or sleepy sub-specialty of ophthalmology, but recent technical advances and significant bets placed by large strategics including Alcon’s planned acquisition of Transcend has injected the sector with enthusiasm and energy. OIS Podcast, in our new KOL Corner features, talks with leading glaucoma specialists about where the field is headed.

The combination of Pfizer and Allergan certainly creates some waves in ophthalmology. But did these choppy waters have anything to do with recent leadership changes in ophthalmology?

EyeGate Pharmaceuticals had hit a wall. Its venture investors were tapped out, and the compa-ny needed capital to continue running clinical trials on its lead product. CEO Stephen From turned to the public markets, leading the company through a unique – and small IPO. With $4 million from the offering, the company signed an agreement with Valeant Pharmaceuticals Inc. to help fund the trial. The partnership enabled the company to raise another $10 million from investors, putting it on track to start a confirmatory Phase III clinical trial.

David Muller came close to writing the final chapter of Avedro’s push to have corneal cross-linking approved by the FDA. But he opted to leave the company before the final approval came through to pursue a new venture called Allotex. In this interview with OIS Podcast, Muller explains his decision to leave Avedro and tells us why he’s excited about this new entrepreneurial endeavor.

Inotek CEO David Southwell and William K. McVicar Ph.D. Executive Vice President, Chief Scientific Officer, share Inotek’s plan to bring to market a new first-line for glaucoma sufferers.

OIS Correspondents Michelle Dalton and Richard Kirkner pool their insights on the most compelling sights and insights of OIS, Subspecialty Day and AAO. The two scribes opine on exiting new disease targets, advances in drug delivery, the penetration of digital technology and why the `Pfizergan’ deal makes sense for ophthalmology.

Allergan has been a pillar of the ophthalmology sector for decades, so it’s merger with Pfizer is creating some concern along with great optimism. But ophthalmology leaders also see the opportunity for potential in the combination. The deal could bring greater firepower to ophthalmology R&D and M&A and some hope it’s a harbinger of more things to come for the sector.

Elisabeth “Eli” de los pinos was enjoying her job at Eli Lilly’s Oncology Business Unit where she was part of the leadership team responsible for Alimta’s market launch in Europe, a new drug for the treatment of Lung cancer. But she took the leap, leaving corporate comfort to build Aura Biosciences from the ground up around viral-like synthetic nanoparticles that are closely related to wild type viruses in structure and behavior but lack any viral DNA. These empty protein shells resemble viruses but do not have the capability to replicate or integrate. Aura is leverage the technology to create AU-011, which can deliver potent cell-killing laser-activated molecule right to the point of ocular cancer. Aura says the molecule is activated by a standard ophthalmologic laser and treatment will be administered in an outpatient visit.

The Ophthalmology Innovation Summit hit it big in Las Vegas prior to the industry’s American Academy of Ophthalmology Annual Meeting. With close to 1,000 registered attendees, OIS@AAO brought innovators together with both public and private investors as well as corpo-rate leaders of our dynamic sector. OIS Podcast walks through the agenda, hitting upon the highlights that include comments from OIS and industry leaders.

Eleven Biotherapeutics last spring issued some disappointing news when its leading project, EBI-005 didn’t fare well in a Phase III trial for Dry Eye. However, the company’s AMP-Rx platform is chugging along and its EBI-005 is making progress against other conditions including allergic conjunctivitis. CEO and President Abbie C. Celniker, PhD, updates OIS Podcast listeners on the pipeline and shares how the company is preparing for the oncoming conference season, which starts with OIS.

Dry eye remains one of the more dynamic sectors of ophthal-mology with Shire’s recent news about its lead Lifitegrast product moving toward FDA approval. Ora knows Dry Eye better than most, and Vice President George Ousler helps fill in the blanks about Dry Eye’s future. Ora also published a paper in the October issue of Review of Ophthal-mology, Delving into the Dry-Eye Pipeline. To access the paper, go here. http://www.oraclinical.com/articles/delving-dry-eye-pipeline

Avedro’s long saga with the FDA continues. Last week, the firm resubmitted the NDA for its riboflavin ophthalmic solution/KXL System, which should be the final step toward the company securing FDA approval. Founder and CEO David Muller explains how the Avedro worked to overcome the latest setback and how he, as the company’s leader, manages expectations of employees, investors, and customers as the company suffers delay after delay. He also gives an update on Avedro’s promising Photorefractive Intrastromal Cross-Linking (PiXL) refractive technology and explains what he learned about himself while running a dairy farm in Vermont.

In July, Biogen signed a potential $1 billion-plus deal with Applied Genetic Technologies Corp. The deal, which included an equity investment, centered around AGTC’s leading gene therapy programs developing treatments for rare ophthalmic conditions X -Linked Retinoschisis (XLRS) and X-linked Retinitis Pigmentosa (XLRP).In this podcast, Josh Mandel-Brehm, Director, Business Development and M&A at Bio-gen,discusses how Biogen and AGTC spoke for over a year before the deal came together. Calling the eye, “the window into the brain,” Mandel-Brehm says neurology-focused Biogen might be looking to find new partners in the future.

David Nierengarten, Managing Director, Wedbush Securities, explains how public market cycles could hit biotech and ophthalmology companies.

Jeffrey D. Marrazzo, Co-Founder and CEO of Spark Therapeutics, discusses the successful Phase III trial of its lead candidate, SPK-RPE65, was able to improve functional vision in patients with a rare form of a genetic disorder known as RPE65-mediated inherited retinal dystrophies. SPK-RPE65 is intended to treat rare blinding conditions caused by mutations in the RPE65 gene, which is linked to subtypes of Leber congenital amaurosis (LCA type 2) and retinitis pigmentosa (RP type 20). Wall St. approved as well--Spark shares rose almost 60% to $70 in trading before the market opened the day of the announcement. The study results represent the first successful randomized, controlled Phase 3 trial ever completed in gene therapy for a genetic disease, Spark executives said.

Implandata Ophthalmic Products GmbH is putting the task of tracking intraocular pressure into the hands of patients. Company Co-founder and General Manager Max G. Ostermeier shares the story of EyeMate, an implantable micro sensor capable of measuring absolute intraocular pressure continuously or on demand.

Ehsan Sadri, M.D., FACS, FAAO discusses the impact MIGS will have on ophthalmology practices and offers his insights on how ophthalmologist will handle pressure from Obamacare and other external forces going forward.

Kurt Riegger, President and COO of OcuSciences, tells a start-up’s tale. OcuSciences’ OcuMet Beacon is being developed to give optometrists and ophthalmologies the ability to see the onset of disease earlier than ever.

Imprimis Pharmaceuticals is disrupting the compound pharmaceutical industry, a segment of health care that’s undergoing significant regulatory upheaval. The company’s line of ophthalmology drugs could reduce or eliminate the need for post-surgical eye drops. Its approach is drawing support from many, including Dr. Richard Lindstrom, who serves on the company’s board.

Australia-based Opthea is moving forward with clinical trials in the US, testing its OPT-302 compound along and in combination with Lucentis as a potential treatment for Wet AMD. CEO Megan Baldwin explains the company’s approach up until now and its plans going forward.

Josh Makower, MD, literally wrote (or co-wrote) the book on Medtech Innovation. Makower is a general partner in New Enterprise Associates most recent fund, but he’s worked with the firm as a Venture Partner or EIR since 1995. Makower founded ExploraMed I, II, III, and IV Inc., a se-ries of NEA portfolio medical device incubators based on the West Coast that have created eight companies over the past 20 years. He also is co-founder of Stanford’s Biodesign Innova-tion Program.

CEO Paul McLean and Medical Director Malik Kahook, MD, explain how they’ll bring Harmoni to the IOL market.

MIGs leader Glaukos Corp. raised over $100 million in an IPO to expand its already command-ing reach in the white hot MIGs Market. Now the company commands a market capitalization close to $1 billion, enriching the venture investors who committed more than $100 million in ven-ture capital to the company. CEO Thomas Burns explains how Glaukos got where it is today and where he sees it – and the entire MIGs market - going.

We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners. We re-viewed numbers Six through Ten in our last episode. In this episode, we’ll review the five most listened to podcasts, including one interview with a guest who appeared in last week’s review.

We’re thrilled to be celebrating the one-year anniversary of the OIS Podcast. We hope you enjoyed these tales of innovation as much as we have. To celebrate milestone we reveal and review the interviews that most resonated with our listeners.

Oculeve’s stunning acquisition by Allergan last week led us back to a conversation we had with Mark S. Blumenkranz, MD, Professor & Chairman of the Department of Ophthalmology, Stan-ford University. Mark S. Blumenkranz is the H.J. Smead Professor and Chairman of the De-partment of Ophthalmology at Stanford University. He received his Baccalaureate, Master of Medical Science, and MD degrees at Brown University, followed by a Residency in Ophthalmol-ogy at Stanford. Dr. Blumenkranz is a noted vitreoretinal surgeon who served as Co-Director of the Retinal Service at Stanford for five years prior to assuming the Chairmanship in November 1997.

OIS Co-Chair Emmett Cunningham explains how Clarus will invest new $500m fund in ophthalmology and beyond. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Oculeve CEO Michael Ackermann Talks About Allergan’s Big Move in Dry Eye. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Bausch &Lomb Surgical’s Andrew Chang Has Big Plans in Ophthalmology Surgical. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Hear from Allergan’s Past and Future: Highlights of interviews with Brent Saunders and Gavin Herbert.

Leaders of Alcon, AMO, Valeant and Zeiss Discuss the Role of Innovation in their Success.

Valeant CEO J. Michael Pearson tells OIS attendees how the controversial company finds new technologies. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Transcend Medical CMO Sean Ianchulev provides update on COMPASS trial and shares company’s plan for the FDA.

Leonard Borrmann, head of R&D at AMO, explains how the company encourages “failing forward” and other innovative qualities to creating new vision devices. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Veteran Ophthalmology Scribes Larry Haimovich of Haimovitch Medical Technol-ogy Consultants and Mike Lachman of EyeQ Research put down the pens and pick up the Mics to share their insights on ophthalmology.

David Muller, CEO of Avedro, addresses delays in the FDA’s review of the company’s riboflavin ophthalmic solution/KXL System for corneal cross-linking and discusses the considerable potential of PIXL.

OIS Co-Chair Bill Link interviews Richard Lindstrom, MD, after awarding him with the Ophthalmology Innovator Award at OIS@ASCRS on April 16 in San Diego.

The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

As venture investors shift to later stages, start-ups will have to look harder for new sources of innovation. A panel at OIS@ASCRS discusses how new sources of capital can sustain the creation of new companies.

For 10 years PowerVision has been advancing its accommodating IOL, Flu-idVision. Co-Founder, CEO and President Barry Cheskin explains how the company has kept its focus on someday capturing a huge piece of the IOL market. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Alphaeon is tapping physicians for unprecedented involvement in finding and funding new treatments. Hear how the company sees the future of health care. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

With just two weeks away from OIS@ASCRS, Conference Co-Chair Bill Link, managing director of Versant Ventures, reviews the highlights of the upcoming meeting includ-ing a tight focus on glaucoma and plenary talk by J. Michael Pearson of Valeant.

Description: Laurent Attias, Alcon’s head of business development and licensing, shares the company’s overall view on where promising innovation should originate.

ASCRS Program Chair Ed Holland Talks ASCRS Meeting, Technology and Oph-thalmology: The Next Generation. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Seattle Ophthalmologist Audrey Talley Rostov explains how she became involved in an international movement to end corneal blindness. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Mark Blumenkranz, MD, has had a hand in starting many exciting biotech, medtechs and digital health companies. Hear how his innovative process begins and what he’s doing to help foster new ideas in ophthalmology. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Alcon’s Warner, Frinzi Discuss the WaveTec Vision Acquisition Details The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Description: Ophthalmology Industry Veteran Russ Trenary Reveals How InnFocus Intends to Capture a Piece of the Growing MIGs Market. The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation. Learn more about: Sponsorship Presenting Companies Any other questions? Contact the producer of OIS, Craig Simak.

Jon Norris, Managing Director of Health Care at Silicon Valley Bank, gives a sneak peak on his coming report on the health care sector and discusses why ophthalmology continues to be a strong source of innovation.The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation.Learn more about:SponsorshipPresenting CompaniesAny other questions? Contact the producer of OIS, Craig Simak.

DigiSight President and CEO Doug Foster explains how mobile technologies like his company’s SightBook app can help save patient vision and help the pharmaceutical industry develop new ophthalmology drugs.The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation.Learn more about:SponsorshipPresenting CompaniesAny other questions? Contact the producer of OIS, Craig Simak.

Vance Thompson, MD, sees patient “Experience” as a secret weapon in building a successful practice. He shares the steps his group takes to ensure patient service is as big a draw as new technologies.The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation.Learn more about:SponsorshipPresenting CompaniesAny other questions? Contact the producer of OIS, Craig Simak.

The ophthalmology patient base often is seen as a single, monolithic mass. But different generations have different needs and must be approached appropriately, says Dr. George O. Waring IV.The Ophthalmology Innovation Summit was created to facilitate meaningful interactions and business partnerships between physicians, entrepreneurs, investors and industry executives who are driving ophthalmic innovation.Learn more about:SponsorshipPresenting CompaniesAny other questions? Contact the producer of OIS, Craig Simak.

Second Sight President & CEO Robert Greenberg, MD, PhD looks back on Sec-ond Sight’s long road to getting FDA approval for Argus II and considers the path not taken.

Eleven Biotherapeutics capitalized on exciting technology and promising clinical results for its lead Dry Eye product to stage a successful IPO in 2014. Abbie C. Celniker, PhD, President and CEO, talks frankly about her leadership style, dealing with public investors, and how she’s man-aging high expectations for lead product EBI-005.

OIS co-chair Cunningham delivers a high altitude review of the much sought after "Year in Review" report he delivers at each event. In this review, Cunningham touched upon his hopes for the sector and OIS.

TearScience CEO Tim Willis discusses the emergence of Dry Eye Disease and details how his company’s diagnostic and treatment for a source of the condition could help meet the increasing interest from physicians and patients.

The FDA turned away Alimera Sciences’ bid to market Iluvien as a treatment for diabetic macular edema three times before finally giving the green light. President & CEO Dan Myers shares what kept his confidence up during this lengthy review and how Alimera Sciences is positioning Iluvien in the DME market.

OIS stalwart Jack Holladay, MD shares details on the work of a task force com-prised of representatives from the American Academy of Ophthalmology and the Food and Drug Administration charged with updating the regulatory agency’s Grid and developing a Guidance Document for Extended Depth of Focus and Accommodating IOLs. The Guidelines should help foster a new age of lenses by enabling lens makers to develop comprehensive regulatory strat-egies that ensure regulatory bodies and industry start and finish on the same page. Go to OIS.Net to review a PowerPoint Holladay has presented at industry conferences.

Prior to starting Ocular Therapeutix, Amar Sawhney, already a successful medtech entrepreneur was a bit concerned about the unique challenges posed by the ophthal-mology sector. Today, with the commercial launch of its ReSure Sealant underway and a suc-cessful IPO completed, Sawhney says he’s more than confident in the plan to build OCUL into a significant ophthalmic player.

Jeff George, President & Global Head of Alcon, shares his optimism for the oph-thalmology sector with attendees at the recent Ophthalmology Innovation Summit in Chicago. George explained what opportunities Alcon was putting research and development dollars to-wards (spoiler, one involves Google.) He also identified what he saw as intriguing companies and technologies outside of Alcon.

At the recent Ophthalmology Innovation Summit in Chicago, Jeff George, Presi-dent & Global Head of Alcon; David E.I. Pyott, CEO of Allergan; Murthy V. Simhambhatla, PhD, President of Abbott Medical Optics; and Ashley McEvoy, Company Group Chairman of Johnson & Johnson Vision Care shared how they balance external innovation with the acquisition of out-side technologies to further the ophthalmic franchises.

At the recent Ophthalmology Innovation Summit in Chicago, Google and Alcon executives shared the origins and potential outcomes of the partnership between the two com-panies. Initially, they hope to develop a contact lens capable of measuring the wearer’s glucose levels but future applications are even bolder.

Dorit B. Donoviel, PhD, Deputy Chief Scientist and Industry Forum Lead of the National Space Biomedical Research Institute, and Randy McDonald, Founder and President of the Magnum Group, discuss a new program created to address ocular disorders associated with space trav-el. In a partnership between government and the ophthalmology industry, a team of clinicians, entrepreneurs and investors will pursue treatments for increased IOP, swelling of the optic nerve, choroidial folds and other maladies.

As Global Head of Development Franchise Ophthalmics at Novartis, Dirk Sauer has overseen the development of Novartis’ blockbuster Lucentis. Now, his focus is on the pharmaceutical gi-ant’s pipeline of retina compounds, including many in the early stages. Hear how Sauer views innovation, both inside and outside of Novartis.

Gobiquity CEO Michael Brownell breaks down the mobile ophthalmology market from the viewpoint of a start-up that’s set to change how kids are diagnosed with amblyopia, the number one cause of vision loss in kids.

Vicente Anido, Jr., PhD’s career has taken him through large companies and private start-ups. He’s taken life science companies public on two occasions, and he’s seen nearly every perspective of the ophthalmology industry. Today, Anido expects big things for Aerie Pharmaceuticals, a clinical-stage pharmaceutical company with two promising treatments for glaucoma in late clinical trials.

Throughout his career, Stephen Slade, MD, has been an early adopter of new ophthalmic technologies, being among the first to use LASIK, and femtosecond lasers in cataract removal. As a seasoned early adopter, Slade expresses some reservations around new “back-office” technologies in his practice – namely EMRs. Despite these concerns, he sees great potential for more therapeutic approaches including Google’s contact lens. Hear Slade’s unique perspective on the role innovation will play in ophthalmology.

CEO David Muller, maps out Avedro’s designs to dominate the corneal cross-linking market and potentially change the game of vision correction.

OIS Co-Chair, Gil Kliman, MD, Managing Director at InterWest Partners, delivers insight on his firm’s decision to concentrate on ophthalmology 15 years ago and shares the many lessons he’s learned during that time.

Richard L. Lindstrom, MD, a long-time supporter of ophthalmology start-ups, looks ahead at the challenges facing physicians and investors as they work to meet the growing demand for ophthalmic treatment in an evolving healthcare industry.

OIS Co-Chair, Emmett T. Cunningham, Jr., MD, recounts the origin of the Ophthalmology Inno-vation Summits and his time at the formative Eyetech Pharmaceuticals, while sharing in earnest his hopes for ophthalmology as an industry.

Eric Donnenfeld, MD, former president of ASCRS, explains technology has profoundly changed how opthalmology is delivered. He also shares some of his priority issues while he was president of the ASCRS including training the next generation of ophthalmic surgeons.

Bill Link, Managing Director at Versant Ventures, explains why opthalmology will continue to be a pillar for Versant's new fund. He also gives helpful advice to entrepreneurs and physicians looking to turn inspiration into innovation.

Jim Mazzo, former head of AMO and recent chairman of AdvaMed, offers his insights on why ophthalmology remains a standout sector in life sciences and what investors and entrepreneurs need to do to find success in Medtech. Also, what should we make of Google's contact lens deal with Novartis?