EyeWorld Today is the official daily of the ASCRS Symposium & Congress. Each issue provides comprehensive coverage editorial coverage of meeting presentations, events, and breaking news
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24 EW SHOW DAILY Sunday, April 21, 2013 ASCRS Symposia Frank talk delivered at FDA symposium by Jena Passut EyeWorld Editor T he current onerous regulatory approval process in the United States has caused the country to continue to be out-of-step with advancing technology in other parts of the world, according to panelists at the "FDA, Industry, and Ophthalmology: What We Don't Have and Why We Don't Have It" symposium held Saturday. Doyle Stulting, MD, PhD, Atlanta, laid out the rules for the drug, device and 510(k) and PMA processes, highlighting the products currently unavailable in the U.S. domestic marketplace. Two medical device manufacturer representatives discussed difficulties that they have had and continue to have in getting products through mature regulatory systems, particularly the FDA. Allen W. Hill, CEO of VisionCare Ophthalmic Technologies, gave a frank speech about what it took to gain regulatory and reimbursement approval for his company's telescope implant for end-stage AMD. In Europe, it took three months, zero amendments, and $1.6 million. In Rolf Schwind talks about the decision not to bring his laser to the U.S. market. the U.S., it took 58 months, 29 amendments, and $28 million. That is one of the main reasons Rolf Schwind decided not to bring his laser to the U.S. market from Germany, despite its overwhelming popularity overseas. To do so, he would need to take out a considerable loan and ensure an impossible 25% market share. continued from page 22 lar surface and then re-evaluate the patient, he said. Other presentations at the symposium focused on incisions with the femtosecond laser, intra-operative aberrometry, and the management of refractive surprises. Symposium leaders also praised use of the new ASCRS IOL power calculator, available at iolcalc.org. EW Editors' note: Dr. Hill has financial interests with Alcon (Fort Worth, Texas), Bausch + Lomb (Rochester, Street Talk N.Y.), Elenza (Roanoke, Va.), and other ophthalmic companies. Dr. Trattler has financial interests AMO, Allergan, (Irvine, Calif.), Bausch + Lomb, and other ophthalmic companies. Dr. Vukich has financial interests with AMO, AcuFocus, Avedro (Waltham, Mass.), and STAAR Surgical (Monrovia, Calif.). Dr. Warren has financial interests with Alcon, Dutch Ophthalmic (Exeter, N.H.), and Genentech (South San Francisco). "The amortization times are totally unacceptable to survive for a medium-sized company," Mr. Schwind said. "Why would Schwind eye-tech-solutions risk this success and, in the worst case, put the whole company at risk?" One of the problems, Dr. Stulting said, is that the FDA comparison for device trials is perfection, not the current standard of care. "The metrics to measure perfection are misleading," he said. "I have a better idea. Compare new products to the care being given now, not to perfection. Sometimes imperfect products may be better than what we now have." Meanwhile, even the rules for interaction with FDA panels have become stilted, he said. "They don't get to sit across the table and have a free interchange like they did 25 years ago," he said. Dr. Stulting provided a long list of drugs and devices that are avail- able widely outside of the U.S. and are backed by years of data, including topography guided LASIK for highly aberrated eyes and crosslinking. "Crosslinking is the standard of care for keratoconus patients all over the world," he said. "We have a couple of years [before it's approved]," he said. "With crosslinking, we can avoid or delay many grafts. In fact, 50% of the 40,000 grafts we performed in the U.S. could be avoided." Another example is the Artificial Iris by HumanOptics AG, a German company, he added. The FDA delayed the initiation of a multi-center U.S. clinical trial by one and a half years by requiring rabbit compatibility studies of the prosthesis, "in spite of ample biocompatibility data in humans," he said. That resulted in significant cost to the company and unnecessary animal testing, which is not allowed in Europe. The FDA then denied the request to include 18-to-21-year-old patients in the study, and required separate PMA for children and adolescents, which meant additional costs and fewer subjects to enroll. Today, the FDA has asked for more sterilization validation information from the HumanOptics, and is now denying all compassionate use applications from companies that do not have an active IDE. "There is no way to get an artificial device of any kind under any program in the U.S. today," he said. EW What are you looking forward to doing in San Francisco? "Getting together with friends and trying a new restaurant or two." – Stephen Whiteside, MD, Austin, Texas "I want to go to the Exploratorium." – Jose Claros, MD, Merida, Mexico "Trying the restaurants in San Francisco." – Zaina Al-Mohtaseb, MD, Pearland, Texas