Data Published in Archives of Ophthalmology Shows Visudyne(TM) Reduces The Risk of Vision Loss Associated With Wet AMD

ATLANTA, and VANCOUVER, British Columbia (PROTEXT) - For the first time in any leading peer-review medical journal, the October issue of Archives of Ophthalmology published extensive positive results from Phase III clinical trials involving Visudyne (verteporfin for injection) therapy to treat 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. The overall results of the study report that Visudyne therapy reduces the risk of vision loss, compared to placebo, during the first year of the study in patients with the wet form of AMD. The comprehensive analysis reveals that Visudyne therapy shows beneficial effects in the total study population. Additionally, the data shows that a subgroup of patients whose lesions were characterized by a specific, more aggressive, disease pattern experienced a large, clinically relevant benefit. Regulatory applications, based on the data, requesting marketing clearance for Visudyne therapy have recently been submitted to the US Food and Drug Administration (FDA), as well as boards of health in the European Union, Switzerland, Australia, and New Zealand. In the United States, Switzerland, Australia and New Zealand, the application has been granted accelerated review status. Wet AMD typically destroys central vision, which is necessary for reading, driving, and recognizing faces. The condition is characterized by the formation of abnormal blood vessels (choroidal neovascularization 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 2 months to 3 years. As the population ages, wet AMD is predicted to increase as a major public health concern, particularly since current treatment options are limited in efficacy and scope. Positive Results in the Broad, Total Study Population Publication of the results of a 12-month analysis from two 24- month randomized double-masked clinical trials involving 609 patients with a variety of CNV lesion characteristics, known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation showed that vision remained stable or improved (defined as a loss of less than 3 lines of vision on a standard eye chart) for 61% of patients treated with Visudyne therapy compared to 46% of patients administered placebo (p<0.001). This result was statistically significant for both the combined and individual studies. Compared to placebo, the beneficial effects of Visudyne therapy with respect to change in visual acuity were observed at the first follow-up period three months after initial treatment and became more pronounced through month 12. The entire change in visual acuity distribution at 12 months differed by an average of 1.3 lines in favor of those patients on Visudyne (p<0.001). "This is a landmark study with results that have the potential to significantly change the way we manage patients developing wet AMD," said Dr. Neil M. Bressler, Chair of the TAP 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, Maryland. "Visudyne therapy offers hope for potentially preserving the vision and independence of many thousands of people diagnosed around the world each year with predominantly classic CNV." Although the goal of Visudyne therapy is to reduce the risk of vision loss, 16% of patients in the treatment group experienced an improvement in vision of one or more lines on a standard eye chart compared to 7% of patients on placebo. This result confirms that the improvement seen in earlier studies with shorter-term follow up was sustainable for at least 12 months. Severe vision loss (defined as a loss of at least 6 lines of vision on a standard eye chart) occurred in 14.7% of patients treated with Visudyne therapy as opposed to 23.7% of patients on placebo (p<0.001). In order to participate in the trials, patients had to have a best- corrected baseline visual acuity of between 20/40 and 20/200 as well as some evidence of the fluorescein angiographic pattern regarded to be the more aggressive type, termed classic CNV. Positive visual acuity results were complemented by similar outcomes for contrast sensitivity evaluations. In addition, fluorescein angiographic assessments demonstrated that Visudyne significantly reduced the risk of lesion growth, was associated with the cessation of leakage from classic CNV and decreased progression in the development of new areas of classic CNV beyond that observed at study entry. Specifically, at 12 months, Visudyne-treated eyes had a lower mean number of contrast sensitivity letters lost (1.3 vs. 4.5, p<0.001) and were less likely to show progression of classic CNV beyond the original lesion (46% vs. 71%, p<0.001), have fluorescein leakage from classic CNV (77% vs. 88%, p=0.002), and have a lesion size larger than 6 disc areas (41% vs. 73%, p<0.001). Substantially Enhanced Results in Specific Subgroup No subgroups were identified in which placebo-treated patients fared significantly better than patients receiving Visudyne therapy. However, the visual acuity benefit observed in the overall population was substantially enhanced in 243 patients whose lesions at baseline constituted predominantly classic CNV (> or = 50% classic). Vision remained stable or improved in 67% of these patients treated with Visudyne therapy versus 39% on placebo (p<0.001). At 12 months, 12% of these patients on Visudyne therapy had lost greater than six lines of vision whereas 33.3% of placebo patients in this subgroup had experienced severe vision loss (p<0.001). "This finding identifies a very clinically relevant and substantial indication for justifying prompt consideration of treatment for AMD patients with subfoveal lesions who present with predominantly classic CNV," said Dr. Bressler. Visudyne therapy well-tolerated The therapy was well tolerated with few adverse events, and less than 3% of patients withdrawing from the study due to adverse events. 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 that occurred in 10% more treated patients; transient mild to moderate transient visual disturbances that occurred in 2% more treated patients; and self- resolving photosensitivity reactions that usually were mild and occurred within 24 hours post-treatment in less than 3% of treated patients. "In addition to the significant reduction in risk of vision loss noted with Visudyne therapy in these trials, we are extremely pleased with the product's excellent safety profile. This is an important finding, particularly since the drug will be used primarily in a population whose average age probably will be around 75," said Dr. Bressler. "We certainly are indebted to the hundreds of patients that participated in this trial," he added, "Their commitment is evident by the fact that over ninety-four percent of the participants given Visudyne or placebo therapy completed their 12-month follow-up exam." Protocol Two-thirds of the 609 participants in the trials received Visudyne via intravenous injection over ten minutes while the remaining one-third were administered a placebo in a masked fashion. Fifteen minutes after the start of the infusion, a non- thermal light was shone into the patient's eye for approximately one and one-half minutes to activate the drug. Once activated, Visudyne selectively affects the abnormal blood vessels, resulting in a greater chance to stop growth of these blood vessels and corresponding vision loss compared to placebo treatment. Re-treatments were administered every three months if leakage was identified on fluorescein angiography. At the 12-month time period, only 64% of the Visudyne-treated patients required re- treatment. Study Conclusions "Based on these results, we recommend the use of Visudyne therapy in the management of AMD patients with subfoveal CNV lesions that are predominantly classic CNV, once the drug is approved by regulatory agencies for commercial use," said the study authors. "The fact that these trials were rigorous and well-controlled makes these results even more compelling," added Dr. Bressler. About Visudyne Therapy and AMD Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI; Toronto). Upon commercialization, CIBA Vision will market the product worldwide while QLT will be responsible for manufacturing Visudyne. Pending regulatory approval, the companies hope to make Visudyne therapy commercially available by early 2000. 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. (Nasdaq: COHR), based in California, and The Carl Zeiss Group, based in Germany. Additional Phase III 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. The wet form of the condition represents an estimated 15% of all AMD cases, but accounts for approximately 90% of the severe vision loss associated with the disease. Worldwide, nearly 500,000 new cases of wet AMD develop each year, 200,000 of which occur in North America. Visudyne therapy is protected by a series of U.S. and foreign issued patents which cover the composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions. Background on CIBA Vision and QLT 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. For more information, visit the CIBA Vision website at www.cibavision.com . CIBA Vision is the eye care unit of Novartis AG, a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998, Novartis Group sales were CHF 31.7 billion, of which CHF 17.5 billion were in Healthcare, CHF 8.4 billion in Agribusiness and CHF 5.8 billion in Consumer Health. The group annually invests more than CHF 3.7 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,000 people and operates in over 140 countries around the world. QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy, an emerging field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative science has advanced photodynamic therapy beyond applications in cancer towards potential breakthrough treatments in ophthalmology and autoimmune disease. In addition to Visudyne therapy, QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the world's only approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe. For more information, visit QLT's web site at www.qltinc.com . Visudyne(TM) is a trademark of Novartis AG PHOTOFRIN(R) is a registered trademark of QLT PhotoTherapeutics Inc. For more information, visit the CIBA Vision web site at www.cibavision.com or the Visudyne therapy website at www.visudyne.com . For more information, visit the QLT web site at www.qltinc.com QLT PhotoTherapeutics Inc. is listed on The Nasdaq Stock Market under the trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT". The foregoing information contains forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Such factors include: risks associated with the commercialization of Visudyne(TM) therapy; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and product development; the Company's history of operating losses and uncertainty of future profitability; competition; rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval; government regulation; uncertainty of access to capital; anti-takeover provisions; and volatility of common share price; among others, all as described in the Company's Annual Information Form on Form 10-K. ots Original Text Service: CIBA Vision Corporation Internet: http://www.newsaktuell.de Contact: Karen Handel or Ann Berry, Corporate Communications of CIBA Vision, 678-415-4208, or fax, 678-415-3592, or Elayne Wandler or Tamara Hicks, Corporate Communications and Investor Relations of QLT PhotoTherapeutics Inc., 1-800-663-5486, or 604-872-7881, or fax, 604-873-0816 Web site: http://www.visudyne.com Web site: http://www.qltinc.com Web site: http://www.cibavision.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT