WALTHAM, Mass.--Summit Technology Inc. has been given the go ahead to market its excimer laser system for photorefractive keratectomy (PRK) correction of myopia in the United States.
The landmark Food and Drug Administration (FDA) approval comes after a decade of development by the pioneer excimer manufacturer. "This news from the FDA is what Summit has been working toward since the company's inception 10 years ago," said Summit President David Muller.
The approval covers the use of the Apex excimer laser to perform PRK for laser correction of myopia from 1.5 D to 7 D using a 6-mm ablation zone.
The milestone approval cushions the lead that Summit achieved throughout the past year as it leapfrogged past main competitor Santa Clara., Calif.-based VisX Inc. in the race toward approval. Muller said the approval's significance is heightened by the fact that "we are the only company in the world to receive approval from the FDA to commercially market and sell excimer lasers for treating nearsightedness."
Summit got the big news on the same day that the FDA's Ophthalmic Devices Panel recommended conditional approvability of VisX's excimer laser system for PRK. The decision, which came through with only one dissenting vote out of a 11, stipulates that the panel re-review the data once again after several conditions are met.
Final approval came for Summit a year and a day after the Ophthalmic Devices Panel recommended conditional approvability.
The approval came at a fortuitous time financially for the New England laser manufacturer, according to a Wall Street Journal report. Summit offered 2.2 million common shares in a secondary offering, which would increase its shares outstanding to 19.2 million shares, WSJ reported. In Nasdaq trading on Friday, Oct. 20, the day approval came through, Summit closed at $40.625, unchanged.
MDs need training
Summit had just finished negotiating with the FDA the contents of a patient education booklet required to be distributed to patients by the treating physicians. "Before doctors can start treating patients, they have to be trained and they have to receive these booklets, so, the official PRK kickoff is still probably several weeks away," Muller said.
Approximately 550 ophthalmologists were slated to be trained to use the Apex excimer laser at the American Academy of Ophthalmology meeting in Atlanta earlier this month bringing the total of Summit-trained physicians to 1,000.
PRK at five locations
Upon approval, St. Louis-based LaserVision Centers Inc. implemented plans to immediately offer PRK at five of its U.S. locations. The company, along with its U.S. partner, Columbia/HCA, intends to initially open as many as 50 excimer laser centers within the next 12 months. Summit will reportedly open 20 or 30 laser "Centers for Excellence" as well, mostly in conjunction with major universities. At present, agreements for such centers have reportedly been signed with the Jules Stein Eye Institute at UCLA, the Rush-Presbyterian-St. Luke's Medical Center in Chicago and the George Washington Medical Center in Washington, D.C.
The American Society of Cataract and Refractive Surgery hailed the FDA's milestone approval. "ASCRS has been a leader in excimer education for both ophthalmologists and allied health personnel. In the post-approval world, we will continue to offer state-of-the-art instruction in refractive surgery techniques and will serve as a rational forum for research and the evaluation of RK, PRK and other evolving surgical corrective techniques, including LASIK."
Summit will reportedly receive per-use user fees of approximately $110 to $125 out of a total fee of $250; the remainder will go to VisX via a 1992 agreement under Pillar Point Partners, the joint venture designed to eliminate patent disputes in the United States, according to FDA's Health News Daily.