Visudyne Therapy Filed With The European Medicines Evaluation Agency

CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI), today announced the filing of Visudyne(TM) therapy with the European Medicines Evaluation Agency (EMEA) for marketing clearance in the European Union (EU) 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 centralized filing, when approved, will allow the marketing of Visudyne in all fifteen EU member states comprising Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, and the United Kingdom. CIBA Vision and QLT plan to submit applications to additional regulatory authorities worldwide, starting with the United States and Switzerland in the coming weeks and Canada and Norway shortly thereafter. "The filing of Visudyne therapy with the EMEA represents another major milestone in the worldwide development efforts of Visudyne we share with CIBA Vision," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "We look forward to submitting additional filings to regulatory agencies throughout the rest of the world." 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 efficacy and only applicable for approximately 10% to 20% of the 500,000 new cases of wet AMD that develop worldwide every year. "We are very excited to move another step closer to offering this therapy to patients developing this devastating disease, particularly those ineligible for existing treatment options," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. "We are acutely aware of the significant impact of AMD on an aging population and the desperate need for an effective therapy." 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 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. 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 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. Visudyne(TM) is a trademark of Novartis AG. PHOTOFRIN is a registered trademark of QLT PhotoTherapeutics Inc. CIBA Vision contacts: Karen Handel or Ann Berry Corporate Communications CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Telephone: (USA) (770) 418-4208 Fax: (USA) (770) 418-4256 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, 001-604-872-7881 Fax: 001-604-873-0816 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 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. For more information, you are invited to visit the CIBA Vision web site at or the Visudyne therapy website at ots Original Text Service: CIBA Vision Corporation Internet: Contact: Karen Handel or Ann Berry, Corporate Communications of CIBA Vision Corporation, 001-770-418-4208, or fax, 001-770-418-4256, or Elayne Wandler or Tamara Hicks, Corporate Communications of QLT PhotoTherapeutics Inc., 1-800-663-5486, 001-604-872-7881, or fax, 001-604-873-0816 Web site: Web site:

Klíčová slova CIBA Vision Corporation

USA, Kanada, OSN, svět a Arktida (us)


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