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FDA Panel to Review Laser Eye Surgery
By Susan Heavey,
Reuters
Posted: 2008-03-18 12:57:06
Filed Under: Health News
SILVER SPRING, Md. (March 17) - 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 FDA panel plans to investigate whether patients have been satisfied with the procedure. Complications have ranged from blindness to double vision to dry eye. 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., as well as 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. 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.
Copyright 2008 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. All active hyperlinks have been inserted by AOL.
2008-03-18 11:30:05
By Susan Heavey,
Reuters
Posted: 2008-03-18 12:57:06
Filed Under: Health News
SILVER SPRING, Md. (March 17) - 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 FDA panel plans to investigate whether patients have been satisfied with the procedure. Complications have ranged from blindness to double vision to dry eye. 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., as well as 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. 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.
Copyright 2008 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. All active hyperlinks have been inserted by AOL.
2008-03-18 11:30:05
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