FDA APPROVES VISUDYNETM FOR TREATMENT
OF "WET" MACULAR DEGENERATION
On April 12, 2000, the U.S.
Food and Drug Administration (FDA) approved Visudyne™ (verteporfin for injection) therapy for the treatment of the "wet" form of age-related macular degeneration (AMD), which is the leading cause of blindness in people aged 50 and over in the western world.
Specifically, the FDA approved Visudyne™ therapy for the
treatment of "wet" macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization (CNV). Medical experts have estimated that some 500,000 new patients develop "wet" macular degeneration every year around the world. Of these new cases, some 40-60% will develop predominantly classic lesions (CNV) during the progression of their disease. Patients with this disease may lose their ability to read, drive a car and recognize faces in as little as two months to three years.
Since the FDA approval, the Visudyne™ therapy is currently
available to eye care professionals and their patients across the United States. The approval was based on one-year data from two twenty-four month random, double-masked, placebo-controlled Phase III trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation.
The results of the TAP Investigation were published in the October 1999 issue of Archives of Ophthalmology, a leading international medical journal. The primary finding of these trials showed that in 243 patients with predominantly classic CNV, vision remained stable or improved in 67% of the patients treated with Visudyne™ therapy compared to 39% of patients on a placebo.
Top-line data has recently been released showing that the beneficial effect and the favorable safety profile of Visudyne™ therapy
observed at the one-year point in time has been maintained out to two years with fewer treatments required in the second year.
"Wet" macular degeneration is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow across the central part of the retina, which is called the macula. These blood vessels leak fluid and eventually cause scar tissue, which
destroys central vision.
Visudyne™ therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne™ is injected intravenously into the patient’s arm. The drug is then activated by shining
non-thermal laser light into the patient’s eye. Visudyne™ therapy involves the use of a specifically-designed laser that produces the low-level, non-thermal light required to activate the drug. Treatment is expected to run $1,200 per session and most patients are expected to require more than one treatment per year. It is important to understand that this drug is not a cure. At best it preserves the status quo: It will not restore vision that has already been lost.
Visudyne™ therapy is protected by a series of U.S. and
foreign-issued patents that cover the composition of matter, formulations and manufacturing, and the method of use in treating the "wet" form of macular degeneration and other conditions. The FDA approval of Visudyne™ therapy was announced on April 12, 2000, by CIBA Vision, the eye-care unit of Novartis, and by QLT PhotoTherapeutics,
Inc.
For more on Photodynamic Therapy, please visit our Archives section.
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