ASIANET: FDA Approves Visudyne(TM) Therapy For AMD

ข่าวต่างประเทศ Monday April 17, 2000 09:22 —Asianet Press Release

FDA Approves Visudyne(TM) Therapy For AMD; A Major Advance in Ophthalmology ATLANTA and VANCOUVER, British Columbia, April 12 /PRNewswire-AsiaNet/ -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI; Toronto) announced today that the U.S. Food and Drug Administration (FDA) has approved Visudyne(TM) (verteporfin for injection) therapy for the treatment of the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world. Specifically, the FDA approved Visudyne therapy for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV). Medical experts estimate that of the 500,000 new patients that develop wet AMD every year around the world, 40-60% will develop predominantly classic lesions during the progression of their disease. Patients with this condition lose their ability to read, drive and recognize faces in as little as two months to three years. "The approval of Visudyne therapy to treat AMD is a landmark event within the field of ophthalmology. As the first approved drug therapy for this devastating condition, Visudyne provides new hope to many of the 200,000 Americans who lose their vision from wet AMD every year," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. "This therapy will be available to eye care professionals and their patients across the country within 24 hours." "This is a proud day for all QLT and CIBA Vision employees," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "We have worked toward this day since we treated the first AMD patient with Visudyne therapy in clinical trials just five years ago. The relatively short development time from discovery to market illustrates not only QLT's capabilities but the importance of having a committed partner like CIBA Vision." The approval was based on 12-month data from two 24-month randomized, 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 patients treated with Visudyne therapy compared to 39% of patients on placebo (p

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