Eyeworld

NOV 2011

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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EW FEATURE 43 "Who innovates and who comes up with therapy? It's a com- plex process," Dr. Cunningham said. "If you look at VEGF inhibition for AMD, clearly we knew about the need but it wasn't until properties of VEGF were found and characterized that people thought about its appli- cation." "Ph.D.s, researchers, and clini- cians have to be collaborative in the development process," said Jason Woody, chief executive officer, Lions Eye Institute for Transplant and Research (LEITR), Tampa, Fla. Clini- cians may see an unmet medical need first, but the Ph.D.s will be doing the gene sequencing and working with researchers to discover and develop the compounds, Mr. Woody said. "You will have a visual impair- ment if you live long enough," Mr. Woody said. "It's the only specialty that can make that statement. Every- one in the world will be affected— everyone. Oncology or diabetes researchers can't make that same claim. At the end of it all, it's about delivering better and quicker care to the patient." "It takes brains to see how something can be improved, but also money and capital," Dr. Lindstrom said. Most innovators look to friends and family, then to angel investors or venture capital- ists, he said. "You'll need proof of concept to get VC funding." Something small, such as a new blade or a new technique, can be de- veloped for as little as $20,000, Dr. Cunningham said. But it might take as much as another $50-100,000 to get a company to produce a proto- type. Some current devices "mostly glaucoma drainage devices, are still sold by their inventors. If you have something that will have a large im- pact on the market, you can build it and sell it yourself. But it's expensive to do that today," he said. Industry's role "One of the duties of the physician- ophthalmologist is to help industry appreciate those unmet needs," Dr. Lindstrom said. "Those needs are not limited to just drugs and de- vices, but include delivery of care, too." Industry is an "essential part of the process and partnership. For me, working with industry was easy," Dr. Fine said. "But you have to realize that anything that changes tech- niques or has a learning curve is as- sociated with anxiety for surgeons." Technology has improved from 10 years ago and will be different 10 years from now, Mr. Woody said. Cataract surgery, for example, can be considered minimalism in ac- tion. But simplification is not always simple, these experts told EyeWorld. Commercialization costs have grown exponentially as well, Dr. Lindstrom said. "A lot of people are giving up. That includes companies as well as individuals," Dr. Lindstrom said. Associations' role Organizations like ASCRS or the Association for Research in Vision and Ophthalmology boldly embrace innovation, while others such as the American Academy of Ophthalmol- ogy (AAO) take a more conservative approach. "Organizations should be proactive and embrace innovation, knowing they have to do so with an eye to conflict of interest," Dr. Cunningham said. ASCRS "promoted innovation and legitimized it by giving a voice to anyone who had an idea," Dr. Fine said. "Having organizations and societies that support physicians and new ways of doing things are impor- tant, but it takes a commitment on the part of those organizations to be willing to encourage and foster new ideas." ASCRS "can and does lobby and is an advocate for innovation," Dr. Lindstrom said. "We as physicians need to be friendly to innovation and to innovators. We need to allow new ideas to be discussed on the podium and not attack people who have new ideas." Dr. Sinskey recalls being denied the opportunity to speak at AAO "for 3 years because they thought my ideas were too radical. ASCRS al- ways has a spot on the podium for new ideas." Professional societies "should serve as a bridge between innova- tors—and that primarily means companies—and the FDA," Dr. Cunningham said. "That's a role they could foster if they wanted to. AAO has a whole program on stan- dards of practice. FDA has advisory committees and they'll pull together thought leaders. But it's a very im- perfect process because the FDA can only call people who are not in any way conflicted, and most of the big thought leaders are conflicted—they consult for these companies." February 2011 November 2011 Innovation in ophthalmology Dr. Hill says this because al- though the iStent has been used suc- cessfully in Europe for more than 6 years, it has not yet received FDA ap- proval. Glaukos has conducted the necessary studies required by the FDA and received favorable re- sponses from the agency regarding the device. Dr. Hill encourages future inven- tors to focus on devices that treat the cause of disease rather than just its symptoms. Like others inter- viewed for this article, Dr. Hill be- lieves that collaboration among engineers, physicians, and biologists can help make the best products for patient care. "We all work in our own little worlds, but it's when the worlds overlap that interesting projects can occur," Dr. Hill said. EW Editors' note: Drs. Henderson, Hill, and Malyugin are the inventors of the products they describe, and they have financial interests with the product companies. Contact information Henderson: bahenderson@eyeboston.com Hill: orangecountyglaucoma@mac.com Malyugin: boris.malyugin@gmail.com Pushing continued from page 41 continued on page 44

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