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EXECUTIVE REPORT
Ophthalmology Innovator Award This year’s Ophthalmology Innovator Award was presented to Mark Forchette, who served as President and CEO of OptiMedica for six years until the company’s acquisition by Abbott Medical Optics (AMO) last year. Under Forchette’s leadership, OptiMedica established itself as a technology leader in the emerging field of femtosecond laser cataract surgery. The presentation was made by OIS co-chair Gil Kliman, MD, Managing Director of Interwest Partners, who also interviewed the award recipient. Forchette described a pivotal moment in his life that occurred during his late teens, when he had the opportunity to speak one-on-one with Ray Kroc, the legendary founder of McDonald’s. This encounter ignited his interest in business and entrepreneurship, and the possibility of someday becoming a CEO. Forchette entered the ophthalmic field 30 years ago when he joined Swiss vitreoretinal instrument manufacturer Grieshaber & Co., eventually leading the company’s U.S. operations. After Grieshaber was acquired by Alcon in 1998, he stayed on and led Alcon’s global vitreoretinal business. Forchette said that it was a difficult decision to leave a market leader like Alcon, but he was attracted by the quality of the people involved with OptiMedica.
“Success in business boils down to two things: you have to have technology that resonates and really delivers, and you’ve got to have passionate people that are committed to it. I saw both of those things at OptiMedica.” Mark Forchette Former CEO - OptiMedica
Forchette recounted a particularly challenging period during the company’s product development stage, when incomplete capsulotomies were noted in some cataract patients treated with the laser. Consistent with OptiMedica’s “patients first” value system and philosophy that “a well defined problem is nearly solved,” the company halted its clinical trial, determined the cause of the problem, and developed a solution. The result was the novel and differentiated LiquidOptics patient interface. Regarding the outlook for femtosecond laser technology, Forchette sees great promise. “You put a great device in the hands of talented, forward-thinking physicians, and there’s no telling how far you can take it. I think there’s a very robust future ahead.”
The Role of OUS Clinical Studies in Ophthalmic Innovation Malvina B. Eydelman, MD, Director of the FDA’s Division of Ophthalmic Device Evaluation noted that a recent review of 10,000 clinical studies showed a marked shift toward OUS sites, with less than 40% of studies currently conducted in U.S. sites, down from about 55% in 2007. Initial clinical testing of some novel devices has also moved to non-U.S. sites, and some devices are being developed exclusively for non-U.S. markets. A major potential consequence of this trend toward more OUS clinical studies is longer total time to gain FDA approval for new products, due to a lack of prior U.S. experience and concerns regarding the applicability of study findings to the U.S. population and U.S. clinical practices. Although U.S. approval can be based solely on OUS data, the FDA encourages companies to include at least some U.S. sites in their clinical trials.