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 thefirst time in any leading peer-review medical journal, theOctober issue of Archives of Ophthalmology published extensivepositive results from Phase III clinical trials involvingVisudyne (verteporfin for injection) therapy to treat the wetform of age-related macular degeneration (AMD), the leading causeof blindness in people over the age of 50 in the western world.The overall results of the study report that Visudyne therapyreduces the risk of vision loss, compared to placebo, during thefirst year of the study in patients with the wet form of AMD. Thecomprehensive analysis reveals that Visudyne therapy showsbeneficial effects in the total study population. Additionally,the data shows that a subgroup of patients whose lesions werecharacterized by a specific, more aggressive, disease patternexperienced a large, clinically relevant benefit. Regulatory applications, based on the data, requestingmarketing clearance for Visudyne therapy have recently beensubmitted to the US Food and Drug Administration (FDA), as wellas 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 grantedaccelerated review status. Wet AMD typically destroys central vision, which is necessaryfor reading, driving, and recognizing faces. The condition ischaracterized by the formation of abnormal blood vessels(choroidal neovascularization or CNV) that grow across thecentral part of the retina, called the macula. These vessels leakfluid and, eventually cause scar tissue, which destroys centralvision in as little as 2 months to 3 years. As the populationages, wet AMD is predicted to increase as a major public healthconcern, particularly since current treatment options are limitedin 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 609patients with a variety of CNV lesion characteristics, known asthe 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 standardeye chart) for 61% of patients treated with Visudyne therapycompared to 46% of patients administered placebo (p<0.001). Thisresult was statistically significant for both the combined andindividual studies. Compared to placebo, the beneficial effects of Visudynetherapy with respect to change in visual acuity were observed atthe first follow-up period three months after initial treatmentand became more pronounced through month 12. The entire change invisual acuity distribution at 12 months differed by an average of1.3 lines in favor of those patients on Visudyne (p<0.001). "This is a landmark study with results that have the potentialto significantly change the way we manage patients developing wetAMD," said Dr. Neil M. Bressler, Chair of the TAP Study AdvisoryGroup, and a retinal specialist and Professor of Ophthalmology atthe Wilmer Eye Institute of the Johns Hopkins University Schoolof Medicine in Baltimore, Maryland. "Visudyne therapy offers hopefor potentially preserving the vision and independence of manythousands of people diagnosed around the world each year withpredominantly classic CNV." Although the goal of Visudyne therapy is to reduce the risk ofvision loss, 16% of patients in the treatment group experiencedan improvement in vision of one or more lines on a standard eyechart compared to 7% of patients on placebo. This result confirmsthat the improvement seen in earlier studies with shorter-termfollow up was sustainable for at least 12 months. Severe vision loss (defined as a loss of at least 6 lines ofvision on a standard eye chart) occurred in 14.7% of patientstreated with Visudyne therapy as opposed to 23.7% of patients onplacebo (p<0.001). In order to participate in the trials, patients had to have abest- corrected baseline visual acuity of between 20/40 and20/200 as well as some evidence of the fluorescein angiographicpattern regarded to be the more aggressive type, termed classicCNV. Positive visual acuity results were complemented by similaroutcomes for contrast sensitivity evaluations. In addition,fluorescein angiographic assessments demonstrated that Visudynesignificantly reduced the risk of lesion growth, was associatedwith the cessation of leakage from classic CNV and decreasedprogression in the development of new areas of classic CNV beyondthat observed at study entry. Specifically, at 12 months, Visudyne-treated eyes had a lowermean number of contrast sensitivity letters lost (1.3 vs. 4.5,p<0.001) and were less likely to show progression of classic CNVbeyond the original lesion (46% vs. 71%, p<0.001), havefluorescein leakage from classic CNV (77% vs. 88%, p=0.002), andhave 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 patientsfared significantly better than patients receiving Visudynetherapy. However, the visual acuity benefit observed in theoverall population was substantially enhanced in 243 patientswhose 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% onplacebo (p<0.001). At 12 months, 12% of these patients onVisudyne therapy had lost greater than six lines of visionwhereas 33.3% of placebo patients in this subgroup hadexperienced severe vision loss (p<0.001). "This finding identifies a very clinically relevant andsubstantial indication for justifying prompt consideration oftreatment for AMD patients with subfoveal lesions who presentwith predominantly classic CNV," said Dr. Bressler. Visudyne therapy well-tolerated The therapy was well tolerated with few adverse events, andless than 3% of patients withdrawing from the study due toadverse events. The majority of adverse events occurred insimilar numbers among the treatment and placebo groups. Thoseevents that occurred more often with Visudyne therapy were:reactions at the injection site that occurred in 10% more treatedpatients; transient mild to moderate transient visualdisturbances that occurred in 2% more treated patients; and self-resolving photosensitivity reactions that usually were mild andoccurred within 24 hours post-treatment in less than 3% oftreated patients. "In addition to the significant reduction in risk of visionloss noted with Visudyne therapy in these trials, we areextremely pleased with the product's excellent safety profile.This is an important finding, particularly since the drug will beused primarily in a population whose average age probably will bearound 75," said Dr. Bressler. "We certainly are indebted to the hundreds of patients thatparticipated in this trial," he added, "Their commitment isevident by the fact that over ninety-four percent of theparticipants given Visudyne or placebo therapy completed their12-month follow-up exam." Protocol Two-thirds of the 609 participants in the trials receivedVisudyne via intravenous injection over ten minutes while theremaining one-third were administered a placebo in a maskedfashion. Fifteen minutes after the start of the infusion, a non-thermal light was shone into the patient's eye for approximatelyone 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 bloodvessels and corresponding vision loss compared to placebotreatment. Re-treatments were administered every three months if leakagewas identified on fluorescein angiography. At the 12-month timeperiod, only 64% of the Visudyne-treated patients required re-treatment. Study Conclusions "Based on these results, we recommend the use of Visudynetherapy in the management of AMD patients with subfoveal CNVlesions that are predominantly classic CNV, once the drug isapproved by regulatory agencies for commercial use," said thestudy authors. "The fact that these trials were rigorous and well-controlledmakes these results even more compelling," added Dr. Bressler. About Visudyne Therapy and AMD Visudyne therapy is being co-developed for various ocularconditions by CIBA Vision Corporation, the eye care unit ofNovartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI;Toronto). Upon commercialization, CIBA Vision will market theproduct worldwide while QLT will be responsible for manufacturingVisudyne. Pending regulatory approval, the companies hope to makeVisudyne therapy commercially available by early 2000. Visudyne therapy involves the use of a specifically designedlaser that produces the low level, non-thermal 689 nm lightrequired to activate the drug. These lasers have been developedby 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 determinethe effectiveness of Visudyne therapy in patients with an earlierstage of AMD who were originally excluded from the TAPInvestigation, as well as patients with a similar but distinctcondition of abnormal blood vessels associated with progressivenear-sightedness known as pathologic myopia. The wet form of the condition represents an estimated 15% ofall AMD cases, but accounts for approximately 90% of the severevision loss associated with the disease. Worldwide, nearly500,000 new cases of wet AMD develop each year, 200,000 of whichoccur in North America. Visudyne therapy is protected by a series of U.S. and foreignissued patents which cover the composition of matter,formulations and manufacturing, and the method of use in treatingAMD and other conditions. Background on CIBA Vision and QLT With worldwide headquarters in Atlanta, Georgia, USA, CIBAVision is a global leader in research, development andmanufacturing of optical and ophthalmic products and services,including contact lenses, lens care products, ophthalmic surgicalproducts and ophthalmic pharmaceuticals. CIBA Vision products areavailable in more than 70 countries. For more information, visitthe CIBA Vision website at www.cibavision.com . CIBA Vision is the eye care unit of Novartis AG, a worldleader 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 CHF17.5 billion were in Healthcare, CHF 8.4 billion in Agribusinessand CHF 5.8 billion in Consumer Health. The group annuallyinvests more than CHF 3.7 billion in R&D. Headquartered in Basel,Switzerland, Novartis employs about 82,000 people and operates inover 140 countries around the world. QLT PhotoTherapeutics Inc. is a world leader in thedevelopment and commercialization of proprietary pharmaceuticalproducts for use in photodynamic therapy, an emerging field ofmedicine utilizing light-activated drugs in the treatment ofdisease. QLT's innovative science has advanced photodynamictherapy beyond applications in cancer towards potentialbreakthrough treatments in ophthalmology and autoimmune disease. In addition to Visudyne therapy, QLT's portfolio of productsinclude PHOTOFRIN(R) (porfimer sodium), the world's only approvedphotodynamic therapy drug, used in the treatment of variouscancers throughout North America, Japan and Europe. For moreinformation, visit QLT's web site at www.qltinc.com . Visudyne(TM) is a trademark of Novartis AG PHOTOFRIN(R) is a registered trademark of QLTPhotoTherapeutics Inc. For more information, visit the CIBA Vision web site atwww.cibavision.com or the Visudyne therapy website atwww.visudyne.com . For more information, visit the QLT web site at www.qltinc.com QLT PhotoTherapeutics Inc. is listed on The Nasdaq StockMarket under the trading symbol "QLTI" and on The Toronto StockExchange under the trading symbol "QLT". The foregoing information contains forward-looking statementswhich involve known and unknown risks, uncertainties and otherfactors which may cause the actual results to be materiallydifferent from any future results, performance, or achievementsexpressed or implied by such statements. Such factors include:risks associated with the commercialization of Visudyne(TM)therapy; dependence on corporate relationships; manufacturinguncertainties; uncertainty of pricing and reimbursement;uncertainties relating to clinical trials and productdevelopment; the Company's history of operating losses anduncertainty of future profitability; competition; rapid growth;uncertainty regarding patents and proprietary rights; productliability claims and insurance; no assurance of regulatoryapproval; government regulation; uncertainty of access tocapital; anti-takeover provisions; and volatility of common shareprice; among others, all as described in the Company's AnnualInformation Form on Form 10-K. ots Original Text Service: CIBAVision Corporation Internet: http://www.newsaktuell.de Contact:Karen Handel or Ann Berry, Corporate Communications of CIBAVision, 678-415-4208, or fax, 678-415-3592, or Elayne Wandler orTamara Hicks, Corporate Communications and Investor Relations ofQLT PhotoTherapeutics Inc., 1-800-663-5486, or 604-872-7881, orfax, 604-873-0816 Web site: http://www.visudyne.com Web site:http://www.qltinc.com Web site: http://www.cibavision.com

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