The Ophthalmic Drugs Subcommittee of the FDA recommended approval of Visudyne therapy for the treatment of wet age-related macular degeneration, the leading cause of blindness among people over age 50. Both the panel and the FDA concluded that Visudyne therapy was most appropriate for patients with predominantly classic subfoveal choroidal neovascularization, the indication proposed by the co-developers, CIBS Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics. The FDA did not ask the advisory panel to formally vote on approvability, but sought guidance on efficacy and confirmation of safety and product labeling. The FDA is expected to make a decision regarding approval on or before Feb. 2.
COPYRIGHT 1999 Lebhar-Friedman, Inc.
COPYRIGHT 2000 Gale Group
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