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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: Gordon A. Langston who wrote (1350)	7/24/1998 11:14:00 AM
From: Jesse	Read Replies (1) \| Respond to of 4140

ALL: off news wire: NEWS STORY FOR VISX 44 07/23 FDA Panel-3-:Members Split On Visx Laser Use In Worst Eyes < SYMBOLS: BEAM VISX I/MDS I/MDV I/MTC G/FDA N/DJN N/DJWI N/HLT N/HOT N/LAT M/NCY M/TEC By Otesa Middleton WASHINGTON (Dow Jones)--A federal panel gave Visx (VISX) conditional backing for its laser system to correct farsightedness, or hyperopia, Thursday. (MORE) DOW JONES NEWS 07-23-98 05:05 PM- - 05 05 PM EDT 07-23-98 The U.S. Food and Drug Administration will make the final decision about approving the device. The agency usually follows the advice of its outside expert panels. If ultimately approved, the Visx laser will be the first such device authorized to correct farsightedness. The laser already is approved for nearsightedness, or myopia, and for correcting astigmatism. The panel recommended the FDA approve the laser under the following conditions: the company continue following patients who have undergone the procedure; the laser's label indicate that women undergoing hormone replacement therapy and people taking antihistimines may heal more slowly; and the company continue to gather long-term patient satisfaction information. In its studies, Visx said the mean time for healing after the laser surgery was less than 5 days. The company's clinical trials looked at the procedure performed on 222 eyes in the U.S. and 53 in Canada. The company said U.S. Census data from the 1980s showed 22% of Americans had hyperopia, or nearsightedness. A Visx competitor, Summit Technology Inc. (BEAM), applied to the FDA earlier this month to have its Apex Plus Laser System cleared for farsightedness. It already is approved for correcting nearsightedness and astigmatism. In February, Summit applied for expanded approval to have the laser cleared for severe nearsightedness. Summit was the first company to get FDA approval to market a refractive surgical laser, in October 1995. (MORE) DOW JONES NEWS 07-23-98 05:35 PM- - 05 35 PM EDT 07-23-98 The company asked the panel to recommend approval of the Visx Star Laser System for the full range of hyperopia, farsightedness that is classified by assigning numbers one to six, six being the worst. The Visx clinical trials, which studied the procedure in 275 eyes in the U.S. and Canada, included 13 eyes in Canada with the worst form of hyperopia, in the four to six range. The FDA panel split over whether there was enough information available to recommend the laser for patients with the most severe form of hyperopia. The panel also said the results of the 222 eyes studied in the U.S. should be examined separately from the 53 eyes studied in Canada, because the vision-testing procedures were different. In its clinical trials, Visx said 95% of the patients were satisfied after the procedure. -Otesa Middleton; 202-862-6654 (END) DOW JONES NEWS 07-23-98 05:39 PM- - 05 39 PM EDT 07-23-98 Comments? Jesse