CIBA Vision and QLT Announce Regulatory Submission

CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing clearance for Visudyne(TM) therapy for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world. The specific indication requested is for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization, the most aggressive cause of vision loss associated with the disease and for which Visudyne showed a dramatic benefit. The companies have requested a priority review within a six- month period as there is no current satisfactory treatment for the majority of patients with wet AMD. Wet AMD is characterized by the formation of abnormal leaky blood vessels (choroidal neovasculature) that grow across the central part of the retina, called the macula. The wet form represents an estimated 15% of all AMD cases but accounts for approximately 90% of the severe vision loss associated with the disease. Currently available treatments are limited in effectiveness and only applicable for approximately 10% to 20% of the 500,000 new cases of wet AMD that develop worldwide every year. "On the heels of filing in the European Union last week, this U.S. submission underscores our commitment to bringing this treatment as quickly as possible to patients throughout the world affected by this deleterious disease," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "There is tremendous demand for more effective treatments for macular degeneration," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. "The approval of Visudyne therapy has the potential to improve the lives of many thousands of people." The submission is based on 12-month data from two 24-month randomized, double-masked, placebo-controlled Phase III trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation. The trials are taking place at 22 centers in North America and Europe and have enrolled a total of 609 patients. At the 12-month follow-up visit, among the 243 patients in the trial with predominantly classic lesions, those treated with Visudyne therapy exhibited a large treatment benefit. Specifically, based on an intent-to- treat analysis, vision was stable (defined as a loss of less than three lines of vision on a standard eye chart) or improved in 67% of these patients treated with Visudyne therapy compared to 39% of patients administered placebo. Accordingly, patients treated with Visudyne therapy were 72% more likely to retain their vision compared to the placebo group. These results were found to be statistically significant in this population for each of the two studies, as well as for the combined data (p<0.001). Statistically significant results on the combined data favoring Visudyne therapy were also obtained for all secondary endpoints, including contrast sensitivity and lesion growth. Visudyne therapy was more likely to confine the growth of the lesion as well as maintain contrast sensitivity relative to patients receiving placebo. Results also showed that Visudyne therapy was well tolerated, with 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 decreased vision that occurred in 2% more treated patients; and self-resolving photosensitivity reactions that usually occurred within 24 hours post-treatment in less than 3% of treated patients. A comprehensive analysis of the data is expected to be published in an upcoming issue of a leading ophthalmic peer- reviewed journal. Top-line results were presented at the Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Florida on May 11, 1999 and at the European Society of Ophthalmology symposium in Stockholm on June 28, 1999. About Visudyne therapy Visudyne therapy can be performed in a doctor's office and is relatively painless to the patient. Visudyne therapy consists of two stages. First, Visudyne is injected intravenously into the patient's arm. It selectively accumulates in the abnormal vessels in the eye. The drug is then activated by shining non-thermal laser light into the patient's eye. Once activated, Visudyne selectively affects the abnormal blood vessels and corresponding vision loss. Visudyne therapy does not appear to damage normal retina vessels on fluorescein angiography, even after multiple treatments. Background on CIBA Vision and QLT: Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision Corporation and QLT PhotoTherapeutics Inc. Upon commercialization, CIBA Vision will market the product worldwide while QLT will be responsible for manufacturing. 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. 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, and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. For more information, you are invited to visit the CIBA Vision website at . 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 100 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. Visudyne(TM) is a trademark of Novartis AG. PHOTOFRIN is a registered trademark of QLT PhotoTherapeutics Inc. Editors Note: The treatment of wet AMD with Visudyne therapy is currently investigational. Only patients who are currently enrolled in clinical trials sponsored by QLT and CIBA Vision are eligible for treatment at this time. Patients and practitioners seeking additional information may view our web site at or call the patient/practitioner hotline In North America, 1-800- 821-2450. CIBA Vision contacts: Karen Handel or Ann Berry Corporate Communications CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Telephone: (USA) (678) 415-4208 Fax: (USA) (678) 415-3592 For more information, you are invited to visit the CIBA Vision web site at or the Visudyne therapy website at QLT PhotoTherapeutics Inc. contacts: Elayne Wandler or Tamara Hicks Corporate Communications QLT PhotoTherapeutics Inc. 520 West 6th Avenue Vancouver, B.C. Canada V5Z 4H5 Telephone: 1-800-663-5486, (USA) (604)872-7881 Fax: (USA) (604) 873-0816 For more information, you are invited to visit the QLT web site at 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 VisudyneO 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: Contact: Karen Handel or Ann Berry, Corporate Communications (USA) 678- 415-4208, Fax, (USA) 678-415-3592, both of CIBA Vision Corporation, or Elayne Wandler or Tamara Hicks, Corporate Communications 1-800-663-5486, or 604-872-7881, or Fax, (USA) 604-873-0816, both of QLT PhotoTherapeutics Inc. 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