FDA OKs Lens Implant for Nearsightedness
Monday, September 13th 2004, 10:54 am
By: News On 6
WASHINGTON (AP) _ An implantable lens to correct nearsightedness won approval from the Food and Drug Administration on Monday.
The lens is permanently implanted in the eye and can offer an alternative to glasses, contact lenses and laser surgery.
The approval covers the Artisan lens made by Ophtec USA Inc., of Boca Raton, Fla. Ophtec president Rich McCarley said the product could be available to surgeons in two weeks. He said the price has not been determined.
Unlike the implanted lenses that replace the eye's normal lens to correct cataracts, this lens is implanted in front of the natural lens. FDA said it is intended to reduce or eliminate nearsightedness in adults with healthy eyes. It should not be used in people who have more than minor astigmatism, the agency said.
FDA said Ophtec studied use of the lens in 662 patients with moderate to severe nearsightedness at 22 medical centers. After three years, 92 percent had 20/40 or better vision, which is considered standard vision necessary to obtain a driver's license, and 44 percent had 20/20 or better.
The agency is requiring the company to do a follow-up five-year study of users of the lens to determine any side effects.
One possible concern, FDA said, is the loss of endothelial cells in the corneas of patients who received the implants. These cells form a layer on the undersurface of the cornea and are essential to keeping the cornea clear.
In the tests, there was a steady loss of endothelial cells of 1.8 percent a year. Officials said it is not known whether this loss will continue at the same rate, or what the long-term effect of this device on the cornea's health might be. The FDA is requiring the lens label to specify it be used only in patients with a dense enough layer of these cells to stand some loss over time.