CHICAGO – A record crowd gathered for the 10th anniversary of OIS@AAO last week in Chicago, and one of the highlights is always the Year in Review delivered by OIS chairman Emmett Cunningham Jr., MD, PhD, MPH, who summarized “a banner year – a remarkable year really” for ophthalmology approvals by the Food and Drug Administration. He noted 10 new drug applications (NDAs)/biologic license applications (BLAs), 65 510(k) device clearances on the pharma side, seven pre-market approvals (PMAs), and two de novo device approvals.
OIS attendees also learned about what it takes to pursue a global strategy, how artificial intelligence and analytics will impact ophthalmology, and what’s going on with funding and the equity markets – plus they received an update from American Academy of Ophthalmology CEO David W. Parke, MD, and heard presentations from 44 companies in various showcases. And that doesn’t include the three investigators conducting research funded by Research to Prevent Blindness or pearls from the Masters of Industry panel. A record 1,100 attendees were there. Presentations are available through the OIS website.
Overview: FDA Changes, Strong Pipeline
In his overview, Dr. Cunningham pointed out that organizational changes at the FDA bode well for ophthalmology. In reviewing the NDAs of the past year, Dr. Cunningham noted that this was the first time he’s had to use two slides to list them all. Looking forward, he commented that gene therapy, dry eye, and refractive errors seemed to be the most promising therapeutic areas.
Sixteen companies are pursuing gene therapy programs in ophthalmology, Dr. Cunningham pointed out. “You can see that gene therapy is valued at over a 200% premium over the markets in this 12-month period that we’ve followed,” he added. “The world likes gene therapy. It’s come of age.”
In dry eye, six new candidates are in Phase III studies, nine others are in Phase II, and more are in preclinical. “There are literally three dozen companies in the dry-eye space that are active and advancing,” he declared. “It’s going to become a very complex and competitive market and how that falls out is going to be hard to predict.”
Pharmacotherapies for presbyopia and myopia represent the “holy grail” in ophthalmology, Dr. Cunningham continued. Novartis, Allergan, Orasis Pharmaceuticals, Presbyopia Therapies, and ViewPoint Therapeutics are pursuing programs in presbyopia. Nevakar, Sydnexis, and Eyenovia have candidates for myopia. “If presbyopia is a mega-market, [myopia] is twice that and growing,” Dr. Cunningham said, noting that 2 billion people worldwide have presbyopia and 5 billion are projected to have myopia by 2050.
While a “mature field,” promising programs for treatment of retinal disease continue to emerge, including brolucizumab (Novartis), the Port Delivery System with ranibizumab (PDS) and faricimab bispecific antibody (Roche/Genentech), sunitinib tyrosine kinase inhibitor (Graybug Vision), the VEGF-C/D inhibitor OPT-302 (Opthea), RGX-314 (REGENXBIO), and the topical anti-VEGF platform PAN-90806 (PanOptica). Three diabetic macular edema candidates – faricimab, risuteganib (Allegro Ophthalmics), and the small-molecule Tie-2 inhibitor AKD-9778 (Aerpio Therapeutics) – are in Phase II or III trials.
On the device side, the FDA has reduced review times of 510(k) applications by 50% in the past year, according to information the agency supplied. Microinvasive glaucoma surgery (MIGS) has been active, with FDA approvals of the iStent (Glaukos) and Hydrus Microstent (Ivantis) in the past year – and the voluntary withdrawal of the CyPass Micro-Stent (Alcon). Two MIGS devices – MicroShunt (Santen) and iStent SUPRA (Glaukos) – are in clinical development. Dr. Cunningham cited MarketScope statistics that project the number of MIGS procedures will more than double to 584,000 by 2023.
Two devices also received de novo approvals – the TrueTear intranasal tear stimulator (Allergan) and IDx-DR (IDx), the first FDA-approved autonomous artificial intelligence-based diagnostic device, which is for screening of diabetic retinopathy. “AI is a big deal and it’s going to totally transform our world,” Dr. Cunningham predicted.
Venture funding in ophthalmic companies remains strong. “This year we’ve had $718 million for ophthalmology,” Dr. Cunningham noted. “It’s really a record-breaking year.” In the past 22 months, the ophthalmology sector has seen $540 million in initial public offerings and $1.1 billion in follow-on activity, according to Piper Jaffray data. Based on the yield curve spread, the market should hold, Dr. Cunningham said. “If this predicts the future we still have a year or two before we can expect a recession.”
RPB, AAO Updates, and More
Brian Hofland, PhD, president of Research to Prevent Blindness, introduced three investigators conducting RPB-funded research into retinal vascular dysfunction, ocular imaging of biomarkers in retina and systemic disease, and new treatments in ocular oncology.
Dr. Parke of the AAO provided an update on the IRIS registry and its venture with Verana Health to optimize the database. The registry has 18,128 member physicians from 5,167 practices and holds data on more than 12 million intravitreal injections, he stated.
During the afternoon panel on building a strong ophthalmology pipeline, principals from seven large ophthalmology players that have engaged in strategic partnerships and acquisitions shared their insights for how smaller companies can pursue strategic relationships for a global strategy. “Gaining feedback early on in the development of the product, both on the regulatory side and the access side, is important because what we found firsthand is that a lot of tremendous work that was done in the US is not applicable on the global scale,” Robert Dempsey of Shire offered.
Participants on a panel focusing on artificial intelligence and analytics noted how AI is changing the diagnosis and treatment of ocular disease, and what their companies are doing in AI. Dimitri Azar, MD, of Verily Life Sciences noted that AI is “never going to replace ophthalmologists; it’s a partnership between the human being and the machine.” Five companies presented their work in AI, and then a panel from five larger companies explored the impact of AI and analytics in ophthalmology. During the session, Dale Wiggins, VP and general manager of Philips HealthSuite digital platform, revealed his company is partnering with Alcon to develop a cloud platform for the latter’s Smart SUITE digital health platform.
In his funding overview, a staple of OIS conferences, Andrew Gitkin, head of West Coast biotechnology investment banking for Piper Jaffray, reported the life science sector is strong, with mid-cap medtech stocks up 83% year to date and mid-cap biotech up 26%. IPO activity is also strong, with 55 deals so far this year – the best year since 2014 – and $6.3 billion in aggregate capital raised year to date, a six-year high.
Michael Lachman, president of EyeQ Research, reported the OIS Index had a strong second year, which ended October 1, gaining 24.5%, versus a loss of 9.9% in its first year. Top positive contributors were Staar Surgical, Glaukos, and Carl Zeiss Meditec.
The full OIS@AAO agenda wrapped up with the Masters of Industry panel, moderated by Jim Mazzo, global president ophthalmic devices of Carl Zeiss Meditec. This iteration featured a wrinkle with leaders of two medical societies – Dr. Parke of the AAO and American Society of Cataract and Refractive Surgery executive director Steve Speares – joining the panel. Their participation was not lost on the panelists, as Bill Meury, chief commercial officer of Allergan, noted that in ophthalmology, the relationship between industry and physicians is unique among specialties. “Ophthalmologists have a greater appreciation for innovation,” he asserted. “They know how to work with industry in ways other specialties don’t.”
E-mail questions and comments to Rich@healthegy.com.
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