* April 25 FDA advisory meeting on LASIK
* Industry wary of the outcome
* Patient stories to be heard
By Susan Heavey
WASHINGTON, April 22 The laser eye surgery
industry is steeling itself ahead of a Friday meeting expected
to draw complaints from patients with blurred vision and other
complications of a popular vision procedure.
Millions of patients have hailed the LASIK procedure for
freeing them from glasses or contact lenses, but others have
have become a vocal bloc railing against the surgery, citing
everything from dry eye to surgical gaffes that left scarring.
Those complaints are set to be the focus of a U.S. Food and
Drug Administration public meeting over patient satisfaction
with LASIK, or laser-assisted in-situ keratomileusis.
The FDA is seeking the advice from a panel of outside
experts about issues surrounding patients' experiences after
"Industry is very concerned about this," said Glenn Hagele,
head of a patient referral group, the Council for Refractive
Surgery Quality Assurance.
FDA's meeting comes as the LASIK industry faces weakening
demand for the procedure amid a softening U.S. economy. The
elective procedure is not covered by most health insurers and
can cost several thousand dollars.
The slowdown has hit LASIK device makers, which include
Advanced Medical Optics Inc EYE.N, Alcon Inc ACL.N and
Bausch & Lomb.
LASIK providers such as TLC Vision CorpTLC.TO and
LCA-Vision Inc LCAV.O also have seen sales slip.
The meeting "could become an overhang for LASIK companies
such as EYE (Advanced Medical Optics) because of the
uncertainty of the panel outcome and the potential for negative
media coverage," Wachovia analyst Larry Biegelsen wrote in a
research note last month.
Biegelsen added that it could turn positive if the FDA's
panel of outside advisers concludes that patients experience a
"relatively high" quality of life in part because of newer,
more accurate lasers.
The FDA, which has said LASIK is safe and effective, has
received 140 reports of patient dissatisfaction between 1998
and 2006 on a variety of complaints from injuries and device
malfunctions to dry eye and other side effects, FDA spokeswoman
Peper Long said.
Known complications from the procedure include lost vision,
severe dry eye, glare and double vision. Patients may also
still have to wear glasses or contact lenses and can experience
a loss of the surgery's effectiveness over time.
While the FDA does not oversee surgeons or companies that
perform LASIK, it does regulate the device makers and in 2006
received four citizen petitions asking the agency to review the
devices used in the procedure.
A variety of industry studies have shown that 95 percent of
patients say they are satisfied with the procedure, with the
remaining 5 percent saying they are very unhappy with their
"Even though it's a small number, LASIK is a very
widespread procedure," Long told Reuters. The FDA is expected
to release documents related to the meeting on Wednesday.
About 12.4 million patients have undergone LASIK since the
mid-1990s, or about 700,000 a year, according to the research
Hagele, whose group screens doctors and charges them to
appear on its Web site, said the meeting is likely to draw
patients with extreme opinions on LASIK, both good and bad.
"It's going to be the people who did not get what they
expected," he said.
Doug MacHatton, a spokesman for Alcon who said LASIK
devices were a small part of the company's business, said the
procedure has a high rate of customer satisfaction, but it was
unclear what could result from the FDA's panel. "It's a little
difficult to project what it could mean," he said.
In addition to the FDA meeting, the agency is joining with
the National Eye Institute and two other industry groups to
conduct a study on LASIK patient satisfaction.
Steve Chesterman, spokesman for Advanced Medical Optics,
said the company supported the study and any effort to improve
LASIK patients' experience and "possibly help screen out
patients who are not appropriate for the procedure." He added
the company would not make a presentation at the FDA meeting.
TLC spokesman James Hyland said the company was waiting to
see what the panel decided.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)