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| |  European Committee Recommends Approval Of Visudyne (Verteporfin) Therapy For Choroidal Neovascularization ATLANTA, GA and VANCOUVER, BC -- December 15, 2000 -- CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT Inc. announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) has recommended the granting of a Marketing Authorisation for Visudyne™ (verteporfin) therapy for choroidal neovascularization (CNV) in patients with pathologic myopia (PM) - a serious eye disorder with a worldwide incidence rate of 50,000 new cases every year. The EU Commission is expected to make a final decision regarding the application for an expanded indication for Visudyne in the next few months. When approved by the EU Commission, Visudyne therapy for pathologic myopia will be available throughout the EU, and the Norwegian and Icelandic authorities will grant corresponding national authorizations. Visudyne is already commercially available in 30 countries for use in age-related macular degeneration (AMD) patients with CNV. CNV is a growth of abnormal blood vessels under the central part of the retina, or macula. These vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight. "This recommendation by the CPMP is excellent news," said Luzi von Bidder, President of the business unit Novartis Ophthalmics wordwide. "We are now one step closer in making this important treatment for pathologic myopia commercially available throughout Europe." Dr. Julia Levy, President and Chief Executive Officer of QLT said, "We are extremely pleased by this decision from the Committee and look forward to helping the many thousands of people around the world who have this serious ocular condition." CNV due to pathologic myopia is caused by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the back of the eye associated with severe near-sightedness or myopia. It generally occurs among people over 30 years of age and can result in a progressive loss of vision for which there is no approved treatment for the majority of patients. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year, excluding Asia where the incidence may be even greater due to a higher prevalence of pathologic myopia. Visudyne is approved for commercial use in AMD patients with predominantly classic choroidal neovascularization (CNV) in 30 countries, including North America, the European Union, Switzerland, Australia, and Israel. CNV is a growth of abnormal blood vessels under the central part of the retina called the macula. These vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight. Visudyne is generally well tolerated and has a favorable safety profile. Visudyne is injected in the arm. Potential side effects include injection site reactions, headaches, blurring, decreased sharpness and gaps in vision, and in one percent to four percent of patients a substantial decrease in vision with partial recovery in many patients. People should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated. In clinical studies, patients required an average of 3.4 treatments during the first year. 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, then a non-thermal laser light is shone into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm 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. Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision and QLT Inc. CIBA Vision markets the product worldwide while QLT is responsible for manufacturing. Visudyne therapy is protected by a series of U.S. and foreign-issued patents on composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions.
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