Welcome to the Ophthalmology Innovation Podcast Where you get Candid Conversations with the Leaders and Drivers of Ophthalmic Innovation. OIS is the Largest and Original Producer of World-Class Ophthalmology Innovation Conferences and Content Since 2009.
Dr. Raj Agrawal’s Dual Missions
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.
Roesky’s Quest: Durable Dry Eye Therapy
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.
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Seizing Opportunities with Novartis’ Dr. Jill Hopkins
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.
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Surfing Between Academic Medicine and Innovation with William Freeman, MD
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.
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Bilal Khan, New World Medical, on Balancing Mission with Profitability
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 trips
That 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
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Success From Failure With Iveric Bio’s Dr. Pravin Dugel
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.
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