Search
Menu
Sheetak -  Cooling at your Fingertip 11/24 LB

FDA Panel Recommends Approval of Coherent Laser

Facebook X LinkedIn Email
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.
Bristol Instruments, Inc. - 872 Series LWM 10/24 MR

Published: November 1999
diode lasersNews & FeaturesLasers

We use cookies to improve user experience and analyze our website traffic as stated in our Privacy Policy. By using this website, you agree to the use of cookies unless you have disabled them.