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P00-9                                                FOOD AND DRUG ADMINISTRATION
April 13, 2000                                       Print Media:        301-827-6242
FOR IMMEDIATE RELEASE                                
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FDA APPROVES TREATMENT FOR WET MACULAR DEGENERATION

The Food and Drug Administration today announced the approval verteporfin for injection (Visudyne), the first therapy to slow vision loss in people with the classic type of "Wet Age-Related Macular Degeneration (AMD)". AMD, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 60 years in the Western World. While 90% of AMD is the "dry" form and only 10% is the "wet" form, the "wet" form destroys vision more quickly.

Wet AMD is caused by the growth of abnormal leaky blood vessels which eventually damage the macula--the area of the eye responsible for central vision which is essential for most visual activities, including reading, driving, and recognizing faces. These abnormal vessels leak fluid and blood into the tissue at the back of the eye, causing a blister to form in the retina, which leads to scarring and the impairment of central vision.

With AMD, the central field of vision is affected in varying degrees, while the peripheral or side vision is retained. Untreated, the majority of eyes affected with wet AMD will become functionally blind within two years.

"Until now, there was no adequate treatment for patients affected with the wet form of AMD," said Dr. Jane E. Henney, Commissioner of Food and Drugs. "However, this new therapy will help slow the vision loss for the many patients who face losing their vision to this debilitating condition."

Visudyne therapy is a two-step combination drug and device treatment process. It is relatively painless, takes about 20 minutes, and can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. It travels throughout the body including the abnormal vessels in the eye. Next, the drug is activated by shining a laser light into the patient's eye for approximately 90 seconds. Once activated, it affects the blood vessels in the area of the treatment which leads to a slower rate of vision decline. Since the drug product is activated by light, the patient must avoid exposure of the skin or eyes to direct sunlight or bright indoor light for 5 days after treatment.

Visudyne therapy slows retinal damage, but it does not stop the vision loss or restore vision in eyes that have been damaged by AMD. Phase 3 clinical trials, which involved 609 patients at 22 centers in North America and Europe, showed that patients treated with Visudyne therapy were more likely to have stable vision (defined as a loss of less than 3 lines of vision on a standard eye chart, such as a change from 20/50 to 20/100) compared to placebo-treated patients at 12-month follow- up examination. Vision was stablized in 61% of patients treated with Visudyne therapy compared to 46% of patients administered placebo.

Visudyne therapy was found to be generally well tolerated, with less than 2% of patients withdrawing from the study due to adverse events associated with the treatment. The adverse events that occurred most frequently with Visudyne therapy were injection site reactions; transient vision disturbances; and photosensitivity (increased sensitivity to light). Unfortunately, a severe vision decrease occurring within 7 days of treatment has been reported in 1-4% of patients. This visual decrease is the equivalent to the loss of 4 or more lines of vision on a standard eye chart.

Visudyne therapy is being co-developed by QLT PhotoTherapeutics Inc. and CIBA Vision Corporation, the eye care unit of Novartis AG. QLT will manufacture Visudyne and CIBA Vision will market the product worldwide.

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