EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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42 EW FEATURE February 2011International techniques and technology June 2012 Eroding boundaries by Michelle Dalton EyeWorld Contributing Editor AT A GLANCE • Asia-Pacific and the Middle East are rapidly growing markets for ophthalmic devices • European regulators are quicker to discuss, evaluate, and approve oph- thalmic devices than in the U.S. • From 2005 to 2011, the U.S. ophthalmic devices board only met five times More and more, industry and physicians are looking outside the U.S. when it comes to innovation I n the not-too-distant-past, bringing an ophthalmic device to market might have been as simple as giving a napkin draw- ing to a manufacturer, and if the manufacturer agreed, he'd invest in the idea and develop the tool. These days, however, the state of the global ophthalmic market is dictated more by regulatory agencies than by surgical innovations, and that's frus- trating companies and physicians alike. EyeWorld spoke to an eclectic mix of industry and surgeons to de- termine just where the ophthalmic device market is, where it's heading, and how that's affecting patient care. Bringing devices to market is "much easier in some parts of the Expanding continued from page 41 Anti-VEGF offers options Overall, Dr. Agarwal is impressed by all of the anti-VEGF agents and what they can offer a wide swath of his retinal patients. "From an oph- thalmic point of view all of these drugs are fantastic," he said. "They are definitely helping the patients; there is no doubt about it because we have this documented every- where in the world." He urged prac- titioners everywhere to begin using these. "The doctor has to move into it because when it affects and helps the patients, it is also going to favor the doctor because he is going to get better results," Dr. Agarwal said. "Anti-VEGF products are a real boon for patients." Dr. Bressler agrees. Going for- ward she thinks that the most pow- erful strategy will be to make these agents more user friendly. "I think that these are wonderful drugs and that what we can accomplish now is enormously different from where we were 10 years ago," she said. "The best means of building upon that is going to be with a longer-acting agent or better ways of delivering it rather than something that is going to be more powerful in terms of vi- sion change or a quicker response." EW Editors' note: This article discusses off-label uses of anti-VEGF drugs. For those with neovascular age-re- lated macular degeneration in the U.S., use of anti-VEGF drugs such as Lucen- tis and Avastin to stabilize blood ves- sels and stop the proliferation of new ones is common practice. Likewise for a host of other retinal diseases these anti- VEGF agents are gaining traction, both here and around the globe, according to Dr. Bressler. Mr. Hurley clarified, "Avastin is not manufactured or ap- proved for use in the eye, and thus we do not promote or support its use in the eye. It was developed and is approved for the treatment of patients with cer- tain forms of cancer. Safety findings from large observational studies suggest the risk of systemic serious adverse events may be higher when injecting Avastin into a person's eye compared to Lucentis, which is approved and manu- factured for use in the eye. Therefore, uncertainty remains about the safety of Avastin in the eye." He added, "We believe Lucentis is the most appropriate treatment for wet AMD, and physicians should have the ability to prescribe the medicine they think is right for their patients." Anti-VEGF agents are well-suited to treat many different retinal condi- tions. "One, they stop blood vessels from growing," Dr. Bressler said. "Two, they seem to stop them from leaking, and both are desirable attributes." Drs. Agarwal and Bressler have no financial interests related to this arti- cle. Mr. Hurley has financial interests with Genentech. Contact information Agarwal: +91-44-2811-6233, dragarwal@vsnl.com Bressler: 410-955-5080, sbressler@jhmi.edu Hurley: 650-225-1000 world than it is here," said Richard L. Lindstrom, M.D., adjunct profes- sor emeritus, ophthalmology depart- ment, University of Minnesota, Minneapolis; founder and attending surgeon, Minnesota Eye Consult- ants, Minneapolis; and the Charles D. Kelman Innovator's Lecture recip- ient at the 2011 ASCRS Annual Meeting. Countries with no regula- tory barriers, such as New Zealand, or those with short review times, such as Europe, are bringing vision- saving devices to market much more rapidly, he said. "Years ago, Japan used to be the last market. Now devices are being approved in Japan before the U.S.," he said. In Japan, the health authori- ties allow any physician to acquire any product the physician believes is in the best interest of patients, he explained. The Middle East is "exploding" in terms of how quickly devices are being approved and accepted by surgeons, said Ed Peterson, president and chief executive officer, AcuFocus, Irvine, Calif. In Europe, regulators work "with a sense of urgency and when they have questions, they are quick to review a company's responses in an effort to approve safe and effec- tive devices," said Barry G. Caldwell, president and chief executive officer, STAAR Surgical, Monrovia, Calif. In the U.S., from 2000-2004, the oph- thalmic medical device board met House of Representatives passes its version of the FDA user fee legislation by Nancey McCann ASCRS Director of Government Relations O n May 30, the House passed its version of the bipartisan FDA user fee legislation, H.R. 5651, by a vote of 387 to 5, setting up a con- ference between the House and the Senate to reconcile the differ- ences between the two versions of the legislation. The legislation includes a 5-year reauthorization for FDA programs that help fund the re- view of medical devices and prescription drugs and also creates user fee programs for generic drugs and generic biologic drugs. The legislation was considered under an expedited procedure known as under suspension of the rules, which requires a two-thirds majority for passage. While this process does not allow amendments, House members did make technical changes to the final bill. The legislation also includes much-needed FDA reforms. The Senate passed its version, S. 3187, by a vote of 96 to 1. The conference committee process is expected to begin in an effort to set up quick votes in both the House and the Senate with the goal of sending the final bill to the President before July 4. While the two bills are similar, some differences do remain in several medical device provisions, as well as in the generic drug pay-fors and drug track and trace language. 12 times and approved 11 products. But from 2005-2011, the board only met five times and only recom- mended two products be approved. Only one of those two has come to market, Mr. Caldwell added. "Research and development is completely restricted compared to how it used to be," said Robert H. Osher, M.D., professor of ophthal- mology, University of Cincinnati College of Medicine; medical direc- tor emeritus, Cincinnati Eye Insti- tute; and the 2009 Charles D. Kelman Innovator's Lecture recipient. The regulatory environment notwithstanding, "innovation and innovative ideas still come from the U.S.," said William J. Link, Ph.D., managing director, Versant Ven- tures, Newport Beach, Calif. "But the ideas are being implemented outside the U.S. We're seeing companies and individuals conceive of the ideas here, but developing them overseas" to bring them to market quicker.