FDA to seek panel's advice on LASIK

By Susan Heavey

WASHINGTON (Reuters) - The U.S. Food and Drug Administration plans to seek advice from a panel of outside experts over whether to provide more information to patients about laser eye surgery, according to documents released on Wednesday.

The FDA's comments come ahead of a public meeting set for Friday to discuss patient satisfaction with the LASIK procedure that some analysts said could cloud an industry already pinched by weakening demand amid a slowing U.S. economy.

Since it was first approved in the mid-1990s, more than 12 million Americans have undergone LASIK by some estimates. Industry experts and doctors agree most patients are satisfied, but the FDA has received some complaints of blurred vision, dry eye and other side effects.

In an FDA memo released on Wednesday, the agency said it would ask its outside experts to discuss what information is currently available for patients considering or undergoing LASIK and whether changes must be made.

While the agency does not regulate LASIK, or laser-assisted in situ keratomileusis, it does oversee the equipment used in the procedure.

"Panel members will be asked to recommend modifications/additions to the FDA's patient labeling and LASIK Website," the FDA wrote.

The FDA also said it will seek advice on how to gather more clinical data. The agency is planning to conduct a study on LASIK patient satisfaction along with the National Eye Institute and two industry groups.

Friday's meeting is expected to draw testimony from patients with strong opinions on the procedure, either because they suffered a mishap, or because their lives have improved without having to use glasses or contacts.

Some analysts said negative patient testimony could weigh on shares of LASIK device makers such as Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

Earnings for the companies have already taken a hit as the weakening U.S. economy softens demand for the elective surgery, which costs thousands of dollars and is usually not covered by health insurance.

"The implications on direct-to-consumer marketing efforts may be more notable, as the companies may find themselves working to adjust their marketing message in order to alleviate concerns over post-LASIK complications," Raymond James analyst John Ransom wrote in a research note.

But Jefferies & Co analyst Peter Bye said the any impact from Friday's meeting would be indirect, depending on media coverage and patient testimony.

"I think direct impact from FDA action is pretty minimal," Bye told Reuters. "From a medical standpoint it's a good procedure."

Advanced Medical Optics shares were off 1.7 percent at $19.93 in late afternoon trading, while Alcon shares were up 1 percent at $153.03, both on the New York Stock Exchange.

TLC Vision shares were off 1.5 percent to $1.27, while the shares of LCA-Vision were up 0.8 percent at $12.18, both on Nasdaq.