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Drug approved to combat major cause of blindness

By ASSOCIATED PRESS
Published July 1, 2006


WASHINGTON - The first drug shown to significantly improve the vision of patients threatened by a major cause of blindness in the elderly won federal approval Friday.

The drug, called Lucentis, treats the wet form of age-related macular degeneration, a disorder where blood vessels behind the retina leak blood and fluid, worsening vision and often causing blindness. An estimated 90 percent of the 1.4-million Americans who have lost their eyesight due to the disorder have the wet form.

Lucentis, made by Genentech, Inc., a South San Francisco, Calif., biotechnology company, inhibits the growth of blood vessels when injected into the eye. Other Food and Drug Administration-approved treatments can arrest progression of the disease, which can lead to blindness in just weeks or months, but none has been shown to significantly reverse deteriorating vision.

Genentech may find Lucentis competing against another of its drugs, the cancer treatment Avastin. Avastin is increasingly used to treat macular degeneration for as little as $17 a dose. Lucentis will cost $1,950 per injection. Each drug is typically injected monthly or bimonthly.

Lucentis and Avastin both block the same protein believed responsible for the blood vessel growth. Early results from Lucentis trials led doctors more than two years ago to begin experimenting with Avastin to treat age-related macular degeneration, commonly called AMD.

Since then, at least 10,000 macular degeneration patients have received Avastin injections, a so-called "off-label" use of the drug. "It's become a worldwide phenomenon," said Dr. Philip Rosenfeld of the Bascom Palmer Eye Institute in Miami.

In clinical trials, nearly 95 percent of participants given monthly injections maintained their vision at one year, compared with the approximately 60 percent who did after receiving another treatment, the FDA said. Approximately one-third of the Lucentis patients also reported improved vision after a year. Genentech said it would start shipping Lucentis on Friday.