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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.
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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
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