FDA to review concerns over laser eye surgery
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.
Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said this week that a number of concerns had been raised about 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. FDA spokeswoman Karen Riley said the meeting date had not been made public.
Companies that could be affected by such a meeting include Lasik device makers such as Santa Ana-based Advanced Medical Optics Inc. and Lasik providers such as TLC Vision Corp. and LCA-Vision Inc.
“Obviously, it’s a technology that has caught on and is used very, very widely,” Schultz said. “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.”
Shultz said the meeting would focus on the quality of patients’ lives after surgery.
Possible complications from the procedure include dry eyes, glare, double vision, 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.
In a research note, Wachovia Capital Markets analyst Larry Biegelsen said the FDA 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 fell 40 cents to $19.22 on Wednesday, two days after hitting a 52-week low of $18.47. LCA-Vision shares fell 47 cents to $12.61. On the Toronto exchange, TLC Vision lost 3 cents to $1.01 Canadian.
