EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/78708
June 2012 International techniques and technology February 2011 EW FEATURE 43 Mr. Caldwell said innovation re- mains alive in the U.S., and concepts will continue to be developed state- side, "but we're generations behind other regions in bringing these con- cepts to market." And that means some companies are not concerned with the U.S. as a market overall. Take, for instance, the Acri.Tec line of IOLs (now owned by Carl Zeiss Meditec [CZM], Jena, Ger- many). Dr. Osher was the medical monitor for the Acri.Lisa Toric; 5 years after CZM bought the Ger- many lens developer, its IOLs have not been submitted for U.S. regula- tory approval. Likewise, several countries have been using corneal crosslinking for years; the procedure and technology are still in develop- ment phases here in the U.S. "European companies' interest to come here is almost nil because of the regulatory process," Dr. Osher said. "The concern about the stiff- ened regulatory environment has become very difficult for many sur- geons to remain creative and free- flowing with ideas. I'm involved in several new technology studies with some pretty exciting things, but they're years and years away from being available." While he em- pathizes with the directive the FDA must follow, "ophthalmologists have always exercised our best judgment on what would improve the delivery of patient care." Include the rapid wealth in- crease in Asian markets from China to Vietnam and Malaysia, and those become viable markets for innova- tive (and sometimes costly) devices. And boundaries are blurring—data collected in European studies are being used for U.S. regulatory sub- mission and vice versa. As a global medical device company, under- standing the various regions' nu- ances and "little quirks" is essential for success—and for getting a prod- uct to market in the first place, Mr. Caldwell said. "That globalizing trend will con- tinue," Dr. Link said, adding early studies are often done outside the U.S. in preparation for U.S. Phase II or III studies. The data is then con- solidated for U.S. regulatory submis- sion. "Data is just data," Mr. Peterson said. "The trend of conducting global studies will continue. The FDA accepts data collected outside the U.S., as long as the data can be pooled." What's the next "big" innovation? Despite the current rigors of regula- tion, innovation will continue to forge ahead in the global market and bring with it new treatment oppor- tunities that will eventually make their way back to the U.S. Mr. continued on page 44 An ASCRS Membership For every stage of your career Whether you're just beginning or experienced in cataract and refractive surgery, ASCRS is the professional society that's right for every stage of your career. Mentors and Innovators As an experienced anterior segment ophthalmologist, you've come to understand the importance of innovation and collaboration. It's through collaboration that ophthalmology improves and expands—at times in great leaps and at times through subtle change. Through its many educational and networking services, ASCRS provides an effective forum for the debate of new ideas and the incremental improvement of technique and outcomes. ASCRS offers the means and the unrestricted opportunity to advance the profession and yourself. Join ASCRS today! The Society for Surgeons AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 4000 Legato Road, Suite 700, Fairfax, VA 22033 • 703-591-2220 • www.ASCRS.org