Visudyne  (verteporfin) therapy confirmed safe and effective for age-related macular  degeneration FORT LAUDERDALE, FL -- May 3, 2000 -- At the Association for Research in Vision and Ophthalmology (ARVO) annual conference held this week in Fort Lauderdale, investigators presented results from clinical  trials studying Visudyne(TM) (verteporfin) therapy for the treatment of various eye diseases, including age-related macular degeneration (AMD), the leading  cause of blindness among people over the age of 50. ARVO is one of the major international vision conferences held every year. The results included data that led the U.S. Food and Drug Administration (FDA) to approve Visudyne on April 12, 2000 as a treatment for AMD patients with predominantly classic subfoveal choroidal neovascularization (CNV). "The approval of Visudyne represented a significant development in the treatment of retinal disease," said Dr. Philip Rosenfeld, retinal specialist at  the Bascom Palmer Eye Institute, Miami. "Prior to the approval of Visudyne,  patients diagnosed with the wet form of AMD were faced with limited treatment  options." Some of the conclusions presented during the various sessions included: *  After two years of treatment Visudyne therapy was confirmed to be safe and  effective. * Approximately twice as many patients on Visudyne therapy with  predominantly classic CNV -- the more aggressive type -- lost less than three  lines of vision, or 15 letters, on a standard eye chart, compared to those  patients on placebo (59.1 percent vs 31.3 percent, respectively) at 24 months. * Patients averaged 5.5 treatments during a two year period. *  Visudyne therapy was well-tolerated. Injection site reactions and visual  disturbances were the most frequently reported adverse events. *  Photosensitivity reactions, commonly associated with other photosensitizers,  rarely occurred (0.6 percent) following Visudyne treatments. This result was obtained in patients advised to stay out of direct sunlight  and strong ambient light for 48 hours. * Early detection and treatment is important since further analysis of results showed that the majority of vision loss in patients on placebo occurred  in initial months and patients with smaller lesions, on average, had better  visual outcomes. * Visudyne is beneficial in ocular conditions involving neovascularization beyond AMD. Positive results were demonstrated with Visudyne in patients with  CNV caused by pathologic myopia -- a degenerative form of near-sightedness that  occurs among people over 30 years of age and promising results were obtained in patients with ocular histoplasmosis syndrome, a condition caused by a fungal infection of the retinal area. "The results presented at this conference really validate the effectiveness  of Visudyne therapy," said Dr. Mark Blumenkranz, Professor and Chairman of  Ophthalmology at Stanford University and retinal specialist at the Zweng  Memorial Retinal Research Foundation in Menlo Park. "The sustained benefit shown in AMD and the initial positive results in patients with CNV due to pathologic myopia and ocular histoplasmosis make Visudyne an important tool for the retinal specialist in the fight against blindness." At 12 months, patients with CNV due to pathologic myopia showed a definite benefit from Visudyne therapy with respect to visual acuity, contrast  sensitivity, lesion size, amount of leakage and other outcomes. Specifically,  86.4 percent of patients receiving Visudyne therapy lost less than three lines  of vision, or 15 letters, on a standard eye chart, compared to 66.7 percent of  patients administered a placebo. Patients in the study, whose average age was 50, received 3.5 treatments during the first 12 months of the study, on average. In an open label safety study involving 26 patients with ocular  histoplasmosis, visual acuity improved from baseline by an average of one line  on a standard eye chart at six months with 27 percent of patients experiencing a  visual acuity improvement of three lines or more. Visual acuity decreased by  less than three lines of vision in 88 percent of patients. At this time 27 percent of patients had visual acuity improvement of three lines or more while only 12 percent of patients had a decrease of three lines or more. 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. Visudyne is then activated by shining  non-thermal laser light into the patient's eye. Visudyne is being co-developed for ocular conditions by CIBA Vision  Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. CIBA Vision markets the product worldwide while QLT retains responsibility for manufacturing the product. 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. 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 Zeiss Humphrey, based in California. With worldwide headquarters in Atlanta, Georgia, USA, CIBA Vision is a global  leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products, ophthalmic surgical products and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. What is wet AMD? Wet AMD destroys central vision and is caused by the growth of abnormal, leaky blood vessels in the eye, beneath the centre of the retina. The leaky vessels cause scarring which wipes out central vision in as little as two months to three years. What is Photodynamic Therapy? Photodynamic therapy is a technology that uses light-activated drugs to treat a wide range of medical conditions. Any disease associated with rapidly growing tissue, including the formation of abnormal blood vessels, can potentially be treated with this technology. Photodynamic therapy is also used as a treatment for cancer and cardiovascular diseases. What is Visudyne? Visudyne is a light activated drug that is used in photodynamic therapy and is the first drug that treats wet AMD. The administration of Visudyne therapy is a two-step process. Visudyne is injected into the patient's bloodstream and is then activated with a non-thermal laser for about 90 seconds. Visudyne was developed by a British Columbia based company, QLT Phototherapeutics Inc. and is marketed by CIBA Vision, a subsidiary of Novartis. Visit http://www.visudyne.com/ Can Visudyne restore lost vision? Visudyne cannot restore vision lost to AMD, but it confines the retinal damage and slows down the progression of the disease. TOP Got a Question? Ask the Doctor!