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Biotech / Medical : VISX -- Ignore unavailable to you. Want to Upgrade?

To: MGV who wrote (1476)	1/13/2000 3:47:00 PM
From: Steven Messina,L.M.T.	Respond to of 1754

SNRS gains approval........ (DOW JONES) DJN: =DJ Sunrise Tech's Laser Successful On 2nd Try At FDA P DJN: =DJ Sunrise Tech's Laser Successful On 2nd Try At FDA Panel By Otesa Middleton WASHINGTON (Dow Jones)--On its second attempt at getting federal panel support for its farsighted laser system, Sunrise Technologies International Inc. (SNRS) won the group's endorsement Thursday, making it likely the new laser will win government approval. Sunrise cleared a major hurdle by winning the panel's support, since the company currently has no product on the market in the United States. The company sold an earlier version of the laser in South Africa, Europe and South America. The panel said the laser should be approved with certain conditions, including that the word "temporary" be used to describe the improvement in vision. The device, the Hyperion LTK laser system, was rejected in July because the panel said the company needed more long-term data and because over time some patients lost some of the vision correction the procedure provided. After the July panel meeting, Sunrise's stock plummeted 75% in one day. This time, Sunrise presented data from two years instead of 18 months and changed the approval it sought. Originally, Sunrise asked the Food and Drug Administration to approve the three-second laser procedure for "correcting" mild-to-moderate hyperopia, the medical term for farsightedness. The company changed that request to "reducing" mild-to-moderate hyperopia "where the magnitude of correction diminishes over time." The company's rationale: hyperopic patients over age 40 continue to lose vision over time as the eye ages and loses elasticity, making it unable to focus on objects near and far. These bifocal-wearing patients, according to Sunrise, will continue to lose vision with or without a laser procedure. The FDA, which doesn't have to follow the panel's advice, will make final decision on the product and its specific approval. Sunrise's study showed that some patients still needed to wear glasses or contacts after the surgery. Also, the procedure worked better on older patients than it did on younger ones. Sunrise said about 37 million of the nation's 60 million farsighted people fall into the mild-to-moderate range and will therefore be eligible for the procedure. The laser works by sending two separate rings of eight lasers into the eye around the field of vision. This warms the collagen around the cornea, causing it to shrink and change shape. (MORE) DOW JONES NEWS 01-13-00 03:30 PM * end of story *