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| |  Visudyne (Verteporfin) Provides Long-term Benefits In Age-Related Macular Degeneration ATLANTA, GA and VANCOUVER, BC -- March 28, 2000 -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. announced positive top-line results from the pivotal Phase III study confirming that the benefit and safety of Visudyne(TM) (verteporfin) therapy in treating the predominantly classic form of age- related macular degeneration (AMD) is sustained over a two-year period. In addition, one-year results from a separate and ongoing Phase IIIb study showed that Visudyne therapy benefits patients with a similar but distinct condition referred to as choroidal neovascularization (CNV) due to pathologic myopia. "These results are significant," said Dr. Neil Bressler, Chair of the Visudyne Study Advisory Group, and retinal specialist and Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, Maryland. "Visudyne therapy showed a sustained benefit over two years with no additional safety issues and fewer treatments required in the second year." A complete analysis of the results is currently underway. Further details will be submitted for publication in a peer-reviewed medical journal and presented at the annual Association of Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida, scheduled for April 30-May 5, 2000. The U.S. Food and Drug Administration (FDA) has not received this data, nor do they need it to complete their review of the Visudyne new drug application (NDA) filed in August 1999. "This is a significant development for patients suffering from wet AMD -- they can now look forward to even more prolonged benefits from Visudyne therapy," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmic Business Unit. "We are pleased to see Visudyne has a durable effect based on the 24-month follow-up data." "We are equally encouraged with the results in the pathologic myopic patients," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "Until now this group of younger patients have had very little hope once diagnosed with the condition-a devastating proposition given that the vast majority of them are still in the workforce. We intend to discuss this potential new indication with the FDA to determine the viability of a supplemental NDA for Visudyne." Visudyne therapy is currently under review by the FDA as a treatment for AMD in patients with predominantly classic CNV. Visudyne therapy received its first regulatory approval in Switzerland in December 1999 and additional submissions remain pending in the European Union, Canada, Australia, New Zealand, Norway, Iceland, Brazil, Argentina and India. Outside of Switzerland, in many countries, the treatment is available through early access programs. In North America, a Treatment Investigational New Drug program, in which approximately 3,300 patients have been treated to date, is ongoing. The study results show that the beneficial effect of Visudyne therapy observed at the 12-month time period has been fully maintained out to two years. These findings are based on 24-month follow-up data from 609 patients with wet AMD who participated in two Phase III multi-center randomized placebo-controlled trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation. In the 242 patients with predominantly classic CNV (those cases for which the therapy is currently under review by the FDA), 59.1 percent of patients treated with Visudyne therapy lost less than 3 lines of vision, or 15 letters, on a standard eye chart, compared to 31.3 percent of patients administered placebo (p<0.001) at 24 months. Visudyne patients also exhibited statistically significant positive results in a number of additional areas including slower lesion growth, reduced leakage, and stable contrast sensitivity -- which may be important everyday for activities such as reading and recognizing faces. Further, the percentage of Visudyne-treated patients that experienced an improvement in vision remained at 13 percent over the 24 months. The results confirm that Visudyne therapy is safe and well-tolerated in the longer-term. The average number of treatments required in the second year decreaed from 3.4 to 2.1 for a total of 5.5 treatments over the 24-month period. The effect of Visudyne therapy for the primary endpoint at 24 months also remained statistically significant in the overall population in the combined studies. Patients who elected to continue treatment beyond the 24-month follow-up period are being followed for an additional two years in an open label study called the TAP extension. The results for patients with CNV due to pathologic myopia are based on a single study involving 120 patients with the condition who were enrolled in a Phase IIIb 24-month multi-center randomized placebo-controlled study called the VIP (Verteporfin In Photodynamic therapy) Trial. At 12 months, patients showed a definite benefit from Visudyne therapy with respect to visual acuity, contrast sensitivity, lesion size, amount of leakage and other outcomes. Specifically, 86.4 percent of patients receiving Visudyne therapy lost less than three lines of vision, or 15 letters, on a standard eye chart, compared to 66.7 percent of patients administered a placebo (p=0.01). Patients in the study received an average of 3.4 treatments during the 12-month period and will continue to be followed for an additional 12-months. CNV due to pathologic myopia is caused by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the back of the eye associated with severe near-sightedness or myopia. It generally occurs among people over 30 years of age and can result in a progressive loss of vision for which there were no proven treatments. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year. One-year results of an additional Phase IIIb multi-center randomized placebo-controlled trial involving 339 AMD patients with a different pattern of CNV, that were not eligible for inclusion in the TAP Investigation, did not show a statistically significant benefit with respect to the primary endpoint at 12 months. Forty-nine per cent (49.3 percent) of patients treated with Visudyne therapy lost less than 3 lines of vision, or 15 letters, on a standard eye chart, compared to 45.6 percent of patients on placebo. These patients will continue to be followed for an additional 12-months. These findings have no impact on the recommendation regarding the beneficial effects of Visudyne therapy for predominantly classic CNV in AMD. Both the TAP and VIP studies confirmed the positive safety profile found with Visudyne therapy. The most frequently reported adverse events attributed to the treatment include injection site events and visual disturbances. In over 3,400 treatments, photosensitivity reactions occurred less than 0.6 percent of the time. AMD is the leading cause of blindness in people over the age of 50 and is caused by a growth of abnormal blood vessels (a condition known as choroidal neovascularization or CNV) across the central part of the retina, or macula. The vessels leak fluid and cause scar tissue that destroys central vision, resulting in a deterioration of sight over a period ranging anywhere from two months to three years. Although the wet form represents an estimated 15 percent of all AMD cases, it accounts for approximately 90 percent of the severe vision loss associated with the disease. Worldwide, approximately 500,000 new cases of wet AMD occur each year and this estimate is expected to grow dramatically as the population ages. Results from 12 months of the TAP Investigation-previously released in January 1999 and subsequently published in the October 1999 issue of the leading peer -- reviewed journal Archives of Ophthalmology -- showed that Visudyne therapy could significantly and safely reduce the risk of vision loss associated with wet AMD. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First Visudyne is injected intravenously into the patient's arm, then a non-thermal laser light is shone into the patient's eye activating the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689nm light required to activate the drug. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. based in California, and the Carl Zeiss Group, based in Germany. Visudyne therapy is being co-developed for various ocular conditions by CIBA Vision 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 on 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, ophthalmic surgical products, and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. CIBA Vision is the eye care unit of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. 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 first approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe. Related Links: CIBA Vision, Novartis AG and QLT PhotoTherapeutics Inc.
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