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ARVO MEETING: Visudyne Preserves Vision In Patients With Wet AMD FORT LAUDERDALE, FL -- May 12, 1999 -- Promising clinical trial results for Visudyne(TM) (verteporfin) therapy to treat wet age-related macular degeneration (AMD) were presented last night at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). Co-sponsored by CIBA Vision and QLT PhotoTherapeutics Inc., the initial 12-month analysis of two on-going 24-month randomised phase III studies (known as the TAP -- Treatment of AMD with Photodynamic Therapy -- investigation), first announced in January 1999, showed that Visudyne therapy preserved vision in a significant number of patients with the wet form of AMD, the leading cause of blindness in people over the age of 50. Presenting the results to leading ophthalmologists and eye care professionals in attendance was Dr. Neil Bressler, chair of the phase III study advisory group and a retinal specialist and professor of ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, MD. "These results are compelling because they come from rigorous, well-controlled trials which prove that this new therapy can alter the progression of wet AMD," Dr. Bressler said. "I believe Visudyne therapy has the potential to change the way ophthalmology is practised with respect to the treatment of some patients with AMD. "It is important to understand that, while this is a promising new treatment because of its ability to confine retina damage, this therapy does not restore vision in eyes that have already been significantly damaged by AMD." A comprehensive analysis of the data is expected to be published in an upcoming issue of a leading ophthalmic peer-reviewed journal. Also presented at ARVO were study design and methodology of two additional phase IIIb studies. These studies are being conducted to assess the safety and efficacy of Visudyne therapy in early-stage AMD patients as well as in those with a similar but distinct condition caused by severe near-sightedness referred to as pathologic myopia. The results of the Visudyne therapy phase III Investigation, which involved 609 patients at 22 centres in North America and Europe, showed that patients treated with Visudyne therapy were 34 percent more likely to have stable vision (defined as a loss of less than three lines of vision on a standard eye chart) or improved vision compared to placebo-treated patients at 12-month follow-up examination. Vision was stable or improved in 61 percent of patients treated with Visudyne therapy compared to 46 percent of patients administered placebo. These results were found to be statistically significant. Results also showed that Visudyne therapy was found to be well tolerated, with less than two percent of patients withdrawing from the study due to adverse events potentially associated with the treatment. The majority of adverse events occurred in similar numbers among the treatment and placebo groups. Those events that occurred more often with Visudyne therapy were: reactions at the injection site; transient vision disturbances; and self-resolving photosensitivity reactions that generally occurred within 24 hours post- treatment. AMD is the leading cause of blindness in people over age 50 in the western world. World-wide, approximately 500,000 new cases of wet AMD occur annually. In North America, approximately 200,000 new cases of wet AMD occur annually. Currently, no satisfactory treatment exists. There are two forms of AMD: wet and dry. The dry form is the most common form and is characterised by yellow deposits on the retina, called drusen. The dry form can progress to the severe or wet form, which is caused by the growth of abnormal leaky blood vessels which eventually damage the macula -- the area of the eye responsible for central vision. The wet form of AMD accounts for only about 15 percent of all cases of AMD, but leads to 90 percent of the severe vision loss associated with the disease. Visudyne therapy can be performed in a doctor's office in about 20 minutes and is relatively painless to the patient. Visudyne therapy consists of two stages. First, the drug -- verteporfin -- is injected intravenously into the patient's arm. It selectively accumulates in the abnormal blood vessels of the eye. The drug is then activated by shining non-thermal laser light into the patient's eye. Once activated, verteporfin selectively affects the abnormal blood vessels, resulting in a cessation of growth of these blood vessels and corresponding vision loss. Visudyne therapy does not appear to damage normal retina vessels on fluorescein angiography, even after multiple treatments. E-mail this page to a friend or colleague! To print, use this version