To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Europe Approves Visudyne (Verteporfin) For Wet Age-Related Macular Degeneration URL: http://www.pslgroup.com/dg/1DB3A2.htm Doctor's Guide July 28, 2000
ATLANTA, GA and VANCOUVER, BC -- July 28, 2000 -- CIBA Vision, the eye care unit of Novartis, and QLT Inc. announced that the European Commission has granted Marketing Authorization for Visudyne™ (verteporfin) for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. Specifically, the Commission's decision is in line with the Committee of Proprietary Medicinal Products' (CPMP's) opinion to recommend Visudyne for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV) throughout the European Union. Medical experts estimate that of the 500,000 new patients that develop wet AMD every year around the world, 40-60 percent 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. Currently, only 10 - 15 percent of the estimated 500,000 patients who develop wet AMD worldwide every year are eligible for existing treatments. "Visudyne therapy is the first approved drug treatment for this devastating condition. Now with approval throughout the European Union, Visudyne will provide new hope to many of the approximately 200,000 patients in the European Union who lose their vision from wet AMD every year," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. "This much needed therapy will be available to eye care professionals and their patients across the European Union within the next few weeks." With this approval, Visudyne is now approved in most of the markets in the Western Hemisphere. In addition to the EU countries, Visudyne is currently approved and commercially available in Argentina, Brazil, Canada, Malta, Switzerland and the United States. Regulatory applications are pending in Australia, New Zealand, South Africa, Mexico and India, among many others. While regulatory reviews are ongoing, Visudyne is currently being made available under various expanded access programs in more than 15 countries. "We are excited about this new approval for Visudyne," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "This is another major milestone in making Visudyne therapy available to improve the lives of so many people on a worldwide basis." The approval was based on 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 after 12 months 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 percent of patients treated with Visudyne therapy compared to 39 percent of patients on placebo (p<0.001). The 24-month results from the TAP Investigation were presented in May at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) and demonstrated that the beneficial effect and the favorable safety profile of Visudyne therapy observed at the 12-month time point have been maintained out to two years. These results also showed that fewer treatments are required in the second year. "With this effective new therapy now available in the European Union, it is increasingly important to heighten the awareness of this condition among the elderly," said Professor Gisele Soubrane from Creteil Hospital near Paris, France. "Despite the high prevalence of AMD, according to a recent study, only 30 percent of adults are familiar with the condition. We encourage everyone over the age of 50 to see their eye care professional in order to identify their risk of developing AMD and to define their specific follow-up schedule." Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow under the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. The drug is then activated by shining non-thermal laser light into the patient's eye. Visudyne therapy involves the use of a specifically designed laser that produces the low level, non-thermal 689 nm light required to activate the drug. Related Links: Visudyne (verteporfin), CIBA Vision, Novartis and QLT Inc.. --------------------------------------------------------------------------------------------- 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. 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