Visx Wins Panel Nod on Laser to Fix Farsightedness
Gaithersburg, July 23 (Bloomberg) -- Visx Inc. won the conditional backing of an expert government panel for a device which would for the first time allow farsighted people to have their vision surgically corrected with a laser.
The independent advisory panel for the U.S. Food and Drug Administration voted unanimously to recommend the full agency clear the new use of the device.
Panel members, however, asked that the company provide follow-up data on the patients it had already studied to assure the long-term safety of the new use.
The panel is still voting on whether the device should be used in patients with more severe vision problems.
The FDA generally, but not always, follows the advice of its expert medical panels. An approval would make Visx the first company to offer a laser surgical option to people who have trouble seeing things that are close.
''It opens up a vast market for them and if they are able to get the approval, it will be a head start above all the other laser companies,'' said John Rooney, an analyst with Hornblower & Weeks, Inc.
The panel acted after markets closed. Earlier, shares of Santa Clara, California-based Visx closed unchanged at 61 3/4. Shares of Visx have gained more than 140 percent since the first week of April, rising on soaring demand for the company's eye- surgery laser systems, higher-than-expected profits, and a settlement of a lawsuit with its only U.S. competitor, Summit Technology Inc.
An approval for the new laser use would likely boost Visx even further.
''They will dominate the farsighted market,'' said Rooney, who has a ''hold'' rating on Visx.
After an initial slow start, the laser vision correction market has taken off as doctors become more comfortable with the procedure and as companies -- led by Visx -- roll out improvements offering flexibility in what kinds of vision problems may be corrected.
A majority of all Americans require vision correction, and spend more than $13 billion annually on glasses and contact lenses. The industry estimates that 37.5 million Americans are prime candidates for laser vision correction.
Although Summit was the first laser company to win an FDA approval for the eye surgery, Visx dominates the market now -- in part because it has pioneered an ever wider range of approved uses for the devices, analysts and company officials say.
And being the first to offer farsightedness correction would dramatically increase the potential for Visx devices. About 22 percent of all Americans have medically defined farsightedness according to the U.S. Census Bureau. The condition accounts for one in every three visits to the eye doctor, experts said.
Data from the company's studies goes ''well beyond'' what the FDA requires for device approval, said Marc Odrich, an assistant professor of ophthalmology at Columbia University and a consultant for Visx.
The company presented data today showing that overall, 92 percent of patients who had the surgery saw with vision of 20/40 or better after the necessary healing period. Other data was presented to show that the laser was precise, with doctors achieving the degree of change they intended, and that the effect was reasonably durable.
There were few side effects, and few patients had ''haze'' effects that lingered after the surgery.
Patients' vision tended to change slightly over the three month intervals between follow up visits; an FDA reviewer questioned whether that showed a trend toward a final, stable correction or if it meant instead that the eye was less stable following surgery.
Ophthalmologists perform photorefractive keratectomy or PRK, using lasers to change the shape of the cornea by removing a thin layer of cells on the surface. That improves the way the cornea focuses or ''refracts'' light to receptors at the back of the eye.
Lasers are currently approved in the U.S. for flattening out the cornea -- the clear window of the eye that sits over the pupil -- to correct most forms of nearsightedness and for correcting astigmatism. The delicate procedures cost about $2,500 an eye.
In the case of farsightedness, a different strategy is required where doctors use the laser to whittle down the outer edges of the cornea, creating a steeper curve to bend and focus light correctly.
Orlando, Florida-based Autonomous Technologies Corp., Nidek Co., a closely held Japanese company, and Bausch & Lomb Inc. are closest to bringing their laser products to the U.S. market, experts say. LaserSight Inc. is also working to secure U.S. approval of a corrective laser, and sells similar products internationally. |
