The U.S. Food and Drug Administration has approved Visudyne therapy for the treatment of the wet form of age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. The clinical trials were directed by the Johns Hopkins University. The Keck School of Medicine of the University of Southern California was one of the lead study centers.
"This is very exciting news for more than 200,000 Americans each year who develop this condition and lose their vision from wet AMD," said Jennifer Lim, M.D., associate professor of ophthalmology at the Keck School of Medicine and one of the lead investigators in the clinical trials leading to the approval of Visudyne therapy. "Until now, we have had no effective treatment for this devastating disease, which destroys the patients' central vision and leaves them unable to read, drive or recognize faces."
Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization) that grow across the central part of the retina, called the macula. These 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. The drug is first injected intravenously into the patient's arm. It is then activated by shining non-thermal laser light into the patient's eye. The activated drug causes closure of the abnormal blood vessels.
Approximately 500,000 new patients develop wet AMD every year around the world. Despite the high prevalence of AMD, a recent study showed that only 30 percent of American adults are familiar with the disease.
"Lack of awareness of macular degeneration is a serious concern," said Dr. Lim. "Patients who are diagnosed early have the best chances for successful treatment. We encourage everyone over the age of 50 to follow the American Academy of Ophthalmology's recommendation and see their eye-care professional once a year for a check up."
Visudyne is being co-developed by CIBA Vision Corp., the eye-care unit of Novartis AG, and by QLT Photo Therapeutics Inc. Upon commercialization, CIBA Vision will market Visudyne worldwide while QLT will be responsible for manufacturing the product.
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