• Most Popular
  • Most Shared

UPDATE 1-US FDA panel to review laser eye surgery

Mon Mar 17, 2008 6:40pm EDT

Stocks

   

(Adds details on complaint, byline; updates share movement)

Stocks

By Susan Heavey

SILVER SPRING, Md., March 17 (Reuters) - U.S. health regulators plan to review whether a popular type of laser eye surgery is improving patients' lives, a senior Food and Drug Administration official said on Monday.

Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with the vision correction procedure, known as laser-assisted in situ keratomileusis, or LASIK.

An agency advisory panel will hold a public meeting to discuss the issue, Schultz said, but he did not give a date.

Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc EYE.N, as well as LASIK providers such as TLC Vision Corp (TLC.TO) and LCA-Vision Inc (LCAV.O).

"Obviously, it's a technology that has caught on and is used very, very widely. And there have been questions raised in terms of ... quality of life and what does it actually do for the patient as opposed to the technology itself," Schultz told reporters.

Shultz said the meeting will focus on the quality of patients' lives after surgery.

Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness.

In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval. The agency said the devices were safe and effective but advisory panel discussions "could complement" its other safety monitoring.

"The postmarket information found within our databases, regarding the devices mentioned in your petitions, does not suggest that at this time, there are adverse events that are unanticipated or occurring at an unexpected rate," the FDA said at the time.

FDA spokeswoman Karen Riley said the meeting date has not been made public, although some analysts have said it could happen as early as next month. The agency's eye-related panel is tentatively scheduled to meet April 24-25, May 15-16, Sept. 18-19 and Nov. 20-21.

In a research note, Wachovia Capital Markets analyst Larry Biegelsen said the meeting could create a cloud over related companies because of an uncertain outcome.

Still, it "could ultimately be positive for companies" if the panelists decide the surgery ultimately helps patients, especially those done with newer technologies, he said.

Advanced Medical shares closed down 4.5 percent to $18.83 on the New York Stock Exchange. LCA-Vision shares closed up 1.4 percent to $13.23 on Nasdaq, while shares of TLC Vision closed down four cents to $1.12 on the Toronto exchange. (Reporting by Susan Heavey, Editing by Andre Grenon and Tim Dobbyn)



More from Reuters

Photo

Iraq regrets Blackwater case dismissal, may sue

BAGHDAD (Reuters) - Iraq expressed its disappointment on Friday with a U.S. federal court ruling that threw out all charges against five Blackwater Worldwide security guards accused of gunning down Iraqi civilians in 2007.

A customer is served at a counter inside a foreign exchange store displaying a poster of various banknotes including the Chinese yuan or renminbi (RMB) in Hong Kong November 20, 2009. REUTERS/Bobby Yip
OUTLOOK 2010:

Be careful what you wish for

Pressure on China to loosen its grip on the yuan will continue but the U.S. should tread carefully. Here are five world market issues to watch.  Full Article 

Aurora, a 20-year-old Beluga whale, swims with her newborn calf after giving birth at the Vancouver Aquarium in Vancouver, British Columbia June 7, 2009. REUTERS/Andy Clark

365 days for the doomed

From polar bears to emperor penguins, endangered species will get top online billing in 2010 during the Year of Biodiversity.  Full Article