Eyeworld

Regulatory, financial hurdles Research costs have escalated expo- nentially and today's investment market "is more and more selective about the projects they'll fund," Dr. Lindstrom said. A new molecule can cost as much as $1 billion to bring to market—and most companies "will not invest that kind of money unless they're really confident it's going to go somewhere. In my opin- ion, the current regulatory system in the U.S. is the largest impediment to innovation." Back in the day, the government stopped phaco "because they consid- ered it too experimental," Dr. Sinskey said. "We had to convince them that would stop progress in surgery." Dr. Fine said, the FDA is "oblig- ated by their rules to review a pro- posal in a certain time, and they're months and months behind. Those months and years of delay cost in- dustry hundreds of millions of dol- lars. Who suffers? The patient." Dr. Fine added that medicines or devices approved in Europe but not here "have not made the Europeans worse off. There are companies with some wonderful products that have decided not to bother going through the regulatory process here in Amer- ica, even if it is the biggest market- place. It's too expensive." Dr. Cunningham said the real issue with the FDA is how to balance safety and efficacy. Although the Agency doesn't "approve" surgery, an elective procedure with a 1:1,000 chance of severe vision loss would not be an acceptable risk—yet physi- cians and patients all recognize the benefit of cataract surgery far out- weighs the risk. "No drug is 100% safe and no device is 100% safe, but what is an acceptable safety burden?" Dr. Cunningham asked. Bringing valuable medicines, de- vices, or techniques to market quicker should be medicine's goal, Mr. Woody said. "Finding the best way to move something forward that benefits the patient can only be done through collaborative efforts." Technology will "always win and always prevail," Dr. Fine said. "And it always becomes less expen- sive. The femtosecond laser will un- dergo unimaginable improvements in techniques in its use in cataract refractive surgery. ASCRS is doing its part to help people understand new technology and recognizing that it's going to play a role in the future of cataract surgery." "We should be advocates of constructive interaction between industry and ophthalmology," Dr. Lindstrom said. "I am, and will al- ways be, passionate about innova- tion." EW Editors' note: Dr. Cunningham founded the Ophthalmology Innovation Summit. Drs. Fine and Sinskey have no financial interests related to their comments. Dr. Lindstrom consults for industry. Mr. Woody is an employee of LEITR. Contact information Cunningham: ecunningham@ clarusventures.com Fine: hfine@finemd.com Lindstrom: 952-567-6051, rllindstrom@mneye.com Sinskey: rsinsk@robertsinskey.com Woody: 813-289-1200 Innovation in ophthalmology November 2011 Creating continued from page 43 First of its kind T he Lions Eye Institute for Transplant and Research (LEITR), Tampa, Fla., is "the first and only combined eye bank and research institute," said Jason Woody, chief executive officer, LEITR. "Before our 12,000-square-feet facility opened, researchers would mostly use animal tissue and created the eye disease process," he said. But now researchers are able to use fresh tissue—some preserved within 4 hours or less postmortem—complete with family history. The board of directors realized the eye bank provided 3,000 corneas a year for transplant, but wanted to make "a much larger change for those in need," Mr. Woody said. The group concentrated its efforts on securing eyes from those that opted for donation and went from 800-1,000 a year for re- search "to almost 3,000 for research every year. When we walk out the door, we have full consent to procure that 85-year-old eye with 20-plus years of glaucoma, a full history of what drops that eye had received, and how the medications changed after a heart attack, for instance," Mr. Woody said. Down the line, Mr. Woody believes having this type of research facility will speed drug development and may bring pharmaceuticals to market quicker. "The FDA may appreciate that the research being done is in a human model, not an animal model," he said. "If a compound can be brought to mar- ket even one day earlier because of that, imagine all the patients who would benefit."

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