To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Priority Review To Visudyne For Age-Related Macular Degeneration URL: http://www.pslgroup.com/dg/122AF2.htm Doctor's Guide August 23, 1999
ATLANTA, GA and VANCOUVER, BC -- August 23, 1999 -- CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. announced today that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the new drug application (NDA) for Visudyne™ (verteporfin for injection) therapy. The priority review status indicates that the FDA will act on the application within six months. CIBA Vision and QLT filed for approval of Visudyne therapy for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world, on August 16, 1999.
Wet AMD is characterized by the formation of abnormal leaky blood vessels (choroidal neovasculature) that grow across the central part of the retina, called the macula. The wet form represents an estimated 15 percetn of all AMD cases but accounts for approximately 90 percent of the severe vision loss associated with the disease. Currently available treatments are limited in efficacy and only applicable for approximately 10 percent to 20 percent of the 500,000 new cases of wet AMD that develop worldwide every year.
Approval for Visudyne therapy was requested specifically for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization, the most aggressive cause of vision loss associated with the disease and for which Visudyne showed a dramatic benefit.
The results of the pivotal Phase III trials, known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation showed a statistically significant benefit at 12 months to those patients treated with Visudyne therapy compared to those administered a placebo. Results also showed that Visudyne therapy was well tolerated, with the majority of adverse events occurring in similar numbers among the treatment and placebo groups. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.