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18 | EYEWORLD DAILY NEWS | MAY 4, 2019 ASCRS NEWS ASCRS ASOA ANNUAL MEETING by Ellen Stodola EyeWorld Senior Staff Writer/ Meetings Editor market. Sometimes, we decide with a company when it's time to get this device off the market, she added. Dr. Eydelman discussed the previous structure within the FDA and the new reorganization. She noted the creation of the Office of Product Evaluation and Quality and the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices. Now, there is one single management chain. She mentioned the role of the Office of Ophthalmic, An- esthesia, Respiratory, ENT and Dental Devices in premarket review, post-market surveillance, compliance actions, and signal management. She said there is now "one stop shopping" with the reorganization. Editors' note: The speakers have finan- cial interests with the companies they represent. are going to use, if these codes get you coverage from insurers, and if the payment is appropriate. Prior to the program lunch break, OIS@ASCRS featured a "FDA Fireside Chat" with Malvina Eydelman, MD, direc- tor of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Center for Devices and Radiological Health (CDRH) at the FDA, and William Boyd, MD, lead medical officer at the FDA. The session was moder- ated by Dr. Lindstrom. Dr. Eydelman discussed the reorganization of the CDRH, which was just formalized, and she noted that this is the "official first day of [the] new structure." CDRH is involved in all aspects of regulation of medi- cal devices, Dr. Eydelman said, including the total product life cycle. The FDA is involved from concept to preclinical assessment to watching products get out to market and what they do on the For millennial patients, Dr. Lindstrom said the primary need for innovation is in the area of re- fractive errors. There are opportu- nities in pharmacology, lens-based surgery, and cornea surgery. Mr. Frinzi further commented on the aging population. People are living longer and healthier lives, he said, but this will cause a lot of stress because there won't be enough ophthalmologists to take care of people. This will encourage more collaboration between optometry and ophthal- mology to help manage patients, he said. Dr. Lindstrom said he finds that much of innovation starts with an unmet need. He also noted that many innovations fail early on, sharing his experience working with different accommo- dating IOL companies that have not panned out. The trick was to figure out early that they didn't accommodate. He mentioned the differences between bringing pharmaceuticals and devices to market. It's the rare group that can bring a pharma- ceutical all the way through the process without additional sup- port, he said. The panelists wrapped up by discussing areas of unmet need. Dr. Lindstrom again mentioned management of refractive errors. He added that when he entered ophthalmology, about 25% of the U.S. population was myopic, and now it's above 40%. Also on the OIS@ASCRS program, John Berdahl, MD, Sioux Falls, South Dakota, led a panel discussion on patient pay vs. insurance reimbursement. A huge question for start-up companies, he said, is how they're going to get paid. He highlighted four paths: the dual aspect rule, seek coverage, seek non-coverage, or do nothing. He also shared four reimburse- ment principles: if you fit in a benefit category, what codes you O IS@ASCRS kicked off on Thursday, May 2 with a welcome from William Link, PhD, San Francisco, who gave an update on the ophthalmology inno- vation cycle. He first highlighted "who attends" OIS meetings, including inventors/entrepreneurs, clini- cians and early adopters, financial partners and venture capitalists, and industry leaders. At this year's OIS@ASCRS, he said there is a good mixture of all of these groups, including attendees from 32 states and 17 countries. He went on to discuss the in- novation cycle, including the many phases involved, from observation and invention to product devel- opment and preclinical work to refining and proof of concept, all the way up to CE mark and FDA approval. A panel discussion of the innovation cycle followed, with Richard Lindstrom, MD, Min- neapolis, Jag Dosanjh, Allergan, Dublin, Ireland, Andy Corley, Yelroc Consulting, Newport Beach, California, Ali Satvat, KKR, Menlo Park, California, and Tom Frinzi, Johnson & Johnson Vision, Santa Ana, California. Dr. Lindstrom discussed the aging population. "For us, age 65 matters because that's when people become eligible for Medi- care," he said. For patients over the age of 65, you want to look at cataracts, glaucoma, dry eye and related diseases, and retinal issues, he said. OIS@ASCRS highlights innovation cycle in ophthalmology and more Dr. Eydelman discusses reorganization within the FDA.

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