FDA Approves Lens Implant

September 14, 2004

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The Food and Drug Administration has approved a plastic lens that is permanently implanted into the eye to correct moderate to severe nearsightedness. The lens, called an intraocular lens (IOL), is similar to the type of lens implant used to restore vision following cataract surgery.

Manufactured by Ophtec USA Inc., of Boca Raton, Fla., the new lens is intended to reduce or eliminate nearsightedness in adults, and will offer consumers an alternative to glasses, contact lenses and laser surgery such as LASIK.

The new IOL, called the Artisan, is intended for use in healthy eyes, in people with stable vision. FDA says it should not be used in people who have more than minor (2.5 diopters) astigmatism (distorted vision caused by an uneven curvature of the cornea). Unlike the IOL implanted during cataract surgery that replaces the eye's natural lens, the new IOL for nearsightedness does not replace the natural lens but is implanted in front of it.

FDA said it approved the new lens based on a review of clinical studies of safety and effectiveness conducted by the manufacturer and on the recommendation of the Ophthalmic Devices Panel of FDA's Medical Devices Advisory Committee. Ophtec studied use of the IOL in 662 patients with moderate to severe nearsightedness at 22 medical centers in the U.S. After three years, 92 percent had 20/40 or better vision (considered standard vision necessary to obtain a driver's license), and 44 percent had 20/20 or better.

One potential concern raised by the study was the loss of endothelial cells in the corneas of patients who received the implants. The endothelium is a layer of cells that line the undersurface of the cornea and are essential to keeping the cornea clear. The three-year data showed a continual steady loss of endothelial cells of 1.8 percent a year. At this point, 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.

To minimize long-term effects of the device on the corneal endothelium, FDA is requiring the labeling for the new lens to specify that it should be used only on patients whose corneal endothelial cells are dense enough to withstand some loss over time.

Other adverse events reported in the study included retinal detachment (0.6%), cataract development (0.6%), and corneal swelling (0.4%). FDA is requiring Ophtec to conduct a five-year post-marketing study to better assess the rate of cataract development, retinal detachment and other eye problems.

The Artisan lens is intended to be a permanent implant. Although it can be removed surgically, vision may not return to what it was before receiving the lens. The lens may not eliminate the need for glasses because the Artisan lens does not correct astigmatism. Glasses may need to be worn for night driving or other activities performed in low light. They may also be needed for reading.

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