If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Switzerland Approves Visudyne For Treatment Of Age-Related Macular Degeneration ATLANTA, GA and VANCOUVER, BC -- December 16, 1999 -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. announced that the Swiss Regulatory Agency --Interkantonale Kontrollstelle fur Heilmittel -- has given approval for the marketing of Visudyne (verteporfin) therapy, for the treatment of the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world.
Specifically, the agency approved Visudyne for the treatment of wet AMD in patients with predominantly classic subfoveal choroidal neovascularization. Visudyne therapy will be made commercially available in Switzerland imminently. The registration application for Visudyne was submitted to the Swiss regulatory agency on August 18th, 1999. Regulatory applications are currently pending in the European Union, Canada, Norway, Iceland, Australia, New Zealand and the US. "The approval of Visudyne by the Swiss regulatory agency is a major event for patients suffering from wet AMD," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmic Business Unit. "At last there is an approved, effective treatment that can help preserve the vision of many patients suffering from this terrible, sight threatening condition. We will make Visudyne available to eye care professionals and their patients across the country in the coming days. "We will also use this approval to apply for a free marketing certificate which will enable us to gain approvals in a number of other markets around the world," said von Bidder. Until now, other treatment options are limited to approximately 15 percent of the 500,000 patients worldwide that develop wet AMD every year. Medical experts estimate that between 40 to 60 percent of all wet AMD cases will develop predominantly classic lesions as the disease progresses. "This is a monumental day for QLT and CIBA Vision," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "We are proud to have been able to transform our discovery of Visudyne into a significant vision saving treatment. Today's achievement is a testament to the strong partnership and successful research collaboration between QLT, CIBA Vision and Novartis."
Wet AMD typically destroys central vision, which is necessary for daily tasks such as reading, driving, and recognizing faces. The condition is characterized by the formation of abnormal blood vessels (choroidal neovasculature or CNV) that grow across the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision in as little as two months to three years. Visudyne is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. Upon commercialization, CIBA Vision will market the product worldwide while QLT will be responsible for manufacturing Visudyne. Visudyne therapy can be performed in a doctor's office as a two-step procedure. First, Visudyne is injected intravenously into the patient's arm. Then the drug is 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. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. based in California, and the Carl Zeiss Group, based in Germany. Additional clinical trials are being conducted to determine the effectiveness of Visudyne therapy in patients with an earlier stage of AMD who were originally excluded from the TAP Investigation as well as patients with a similar but distinct condition of abnormal blood vessels associated with progressive near-sightedness known as pathologic myopia. Visudyne therapy is protected by a series of U.S. and foreign issued patents that cover the composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions.
Related Links: CIBA Vision Corporation, Novartis AG and QLT PhotoTherapeutics Inc.
|
