FDA Panel Recommends Approval of Coherent Laser
SANTA CLARA, Calif., Nov. 22 -- The Ophthalmic Drugs Subcommittee of the US Food and Drug Administration has recommended approval of Coherent Inc.'s Opal Photoactivator and Visudyne Therapy for use in treating the wet form of age-related macular degeneration (AMD). Both the panel and the FDA concluded that Visudyne therapy was most appropriate for patients with predominantly classic subfoveal choroidal neovascularization, as had been proposed by the treatment's co-developers, CIBA Vision -- the eye care unit of Novartis AG -- and QLT PhotoTherapeutics Inc.
Coherent and QLT PhotoTherapeutics jointly filed the New Drug Application for Visudyne therapy with the FDA on August 16, 1999. The application covers Coherent's Opal Photoactivator laser, a 689-nm diode laser developed specifically for use in photodynamic therapy, and Visudyne, the drug that is activated by the laser. CIBA Vision Corp. will market Visudyne worldwide.
The FDA will take the panel's recommendation into consideration during the completion of its review of the Visudyne application. The agency's final decision is expected by February 2, 2000.
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