Visx's Laser Eye Surgery Device OKd
By
James F. Peltz, Times Staff Writer
Visx Inc., the leading maker of laser eye surgery gear, won federal
approval Friday to sell a new technology that many believe will reignite growth
in the eye-correction market.
The Food and Drug Administration authorized the "wavefront-guided"
system developed by Santa Clara, Calif.-based Visx for correcting
nearsightedness and an eye malady called astigmatism. Visx is conducting human
trials of its effectiveness on farsightedness.
"We are very pleased" by the FDA's decision, Visx Chief Executive
Elizabeth Davila said in a statement.
Swiss competitor Alcon Inc. already is selling its version of
wavefront-guided technology, having received FDA approval several months ago to
treat nearsightedness. Visx, though, has nearly 60% of the
Friday's announcement came after financial markets closed. Visx's stock gained
47 cents to $17.06 a share on the New York Stock Exchange. The stock has more
than doubled in price since early March amid expectations that the FDA would
give its OK.
Proponents of the new technology say it provides vastly better results than
established laser surgeries, the most popular of which is dubbed Lasik, short
for laser-assisted in-situ keratomileusis. The new technology, in effect, maps
the individual makeup of a person's eyes and enables surgeons to do
"customized" treatments.
The wavefront-guided system provides not only "sharper vision but also
improved night vision" compared with existing technology, said Dr. Robert
Maloney, a
Visx and others hope the improvement will get the laser- correction industry
growing again. Demand soared in the 1990s but then peaked in 2000 — at 1.42
million
Because the surgery typically is elective and not covered by insurance, many
blame the poor economy for damping demand. Lingering consumer fears about the
surgery's safety also are a factor, and some ascribe the slowdown to people
waiting for the wavefront technology to arrive.
The decline also has eroded the earnings of Visx and others in the industry.
Visx's stock, though up sharply this year, is down significantly from more than
$100 a share since the industry's zenith in 1999.
But the new technology's effect "will be minimal at first," said
Market Scope President David Harmon. Over time it "will lead to better
word of mouth and more referrals and increased volume, but in the short run we
won't see a huge increase."
The number of
Visx noted, however, that it already has sold the wavefront equipment to many
of its existing laser surgeons, and they simply have been awaiting FDA
approval. The equipment, costing about $65,000, is about the size of a personal
computer and provides the precise eye measurements the surgeon needs to perform
the operation.
The procedure also will cost more. Currently, Visx charges surgeons $100 for
each procedure they do with a Visx machine, a sum doctors
pass on to patients. Davila previously had said that fee would go up
"substantially" after Visx won FDA approval of its new system.
The average fee for laser surgery is about $1,600 an eye, and that's likely to
rise to about $2,000 with the new technology, Harmon said.