FDA Approves Drug to Treat Eye Disease

WASHINGTON — The Food and Drug Administration on Friday approved a new drug designed to treat the leading cause of blindness in older Americans.

Age-related macular degeneration destroys the light-sensitive tissue in the center of the retina, causing vision to fail gradually from the center outwards.

The new drug, Macugen, attacks the rapidly progressing "wet" type of AMD, in which new blood vessels form behind the retina and then leak, damaging the macula.

That form affects an estimated 1.6 million Americans over 50, and some 6.3 million are expected to be affected by 2030 as the massive "baby boom" generation ages.

Macugen inhibits the protein VEGF, slowing the growth of these blood vessels. VEGF has been shown to play a role in abnormal blood vessel growth.

"It’s the first pharmaceutical directed to the basic pathology of the disease," said Dr. Donald J. D’Amico, a professor of ophthalmology at Harvard Medical School, who conducted clinical trials of the drug.

D’Amico said that untreated patients had about a 45 percent chance of significant vision loss in a year compared to 30 percent for patients treated with Macugen.

Macugen, chemically known as pegaptanib sodium injection, is being jointly developed and marketed by Eyetech Pharmaceuticals and Pfizer Inc. It is expected to be available to doctors early next year.

It is injected into the vitreous gel in the eye, D’Amico said. He said the injections were well tolerated by the patients, with more than 90 percent continuing with the treatment.

Other treatments for wet AMD include laser surgery to destroy the fragile, leaky blood vessels or a light-sensitive drug that is injected and then activated to destroy the blood vessels by shining a light in the eye. Neither is a cure, though they can slow progression of the disease, according to the National Institutes of Health.

Only a small percentage of people with wet AMD can be treated with laser surgery, which can also destroy nearby healthy tissue, and not all patients can be treated with the light-activated drug either, since the leaky blood vessels are not always visible.

Macugen was able to be used in all patients with the wet form of macular degeneration, D’Amico said.

While regular injections of Macugen helped slow vision loss, the treatment did not restore sight that had already been lost.

In the trials, some patients reported red, swollen, itchy eyes from inflamed tissues within a week of the injection, the company said. But officials attributed that to the injection process rather than the drug.

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On the Net:

Food and Drug Administration: http://www.fda.gov