Macular Degeneration News
|Europe Approves Visudyne (Verteporfin) For Wet Age-Related Macular Degeneration |
Health Canada Approves Visudyne (Verteporfin) for Age-Related Macular Degeneration
|AAO: Rheophoresis Flushes Blood-stream To Treat Age-Related Macular Degeneration |
By Cameron Johnston
Special to DG News
DALLAS, TX -- October 23, 2000 -- Investigators are using an experimental, patented process, which is similar to kidney dialysis, to flush toxins from the blood stream, and which they claim is beneficial in treating some patients with a certain form of age-related macular degeneration (ARMD).
|Europe Approves Visudyne (Verteporfin) For Wet Age-Related Macular Degeneration |
ATLANTA, GA and VANCOUVER, BC -- July 28, 2000 -- CIBA Vision, the eye care unit of Novartis, and QLT Inc. announced that the European Commission has granted Marketing Authorization for Visudyne (verteporfin) for the treatment of wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50.
Specifically, the Commission's decision is in line with the Committee of Proprietary Medicinal Products' (CPMP's) opinion to recommend Visudyne for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV) throughout the European Union. Medical experts estimate that of the 500,000 new patients that develop wet AMD every year around the world, 40-60 percent will develop predominantly classic lesions during the progression of their disease. Patients with this condition lose their ability to read, drive and recognize faces in as little as two months to three years. Currently, only 10 - 15 percent of the estimated 500,000 patients who develop wet AMD worldwide every year are eligible for existing treatments.
"Visudyne therapy is the first approved drug treatment for this devastating condition. Now with approval throughout the European Union, Visudyne will provide new hope to many of the approximately 200,000 patients in the European Union who lose their vision from wet AMD every year," said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. "This much needed therapy will be available to eye care professionals and their patients across the European Union within the next few weeks."
With this approval, Visudyne is now approved in most of the markets in the Western Hemisphere. In addition to the EU countries, Visudyne is currently approved and commercially available in Argentina, Brazil, Canada, Malta, Switzerland and the United States. Regulatory applications are pending in Australia, New Zealand, South Africa, Mexico and India, among many others. While regulatory reviews are ongoing, Visudyne is currently being made available under various expanded access programs in more than 15 countries.
"We are excited about this new approval for Visudyne," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "This is another major milestone in making Visudyne therapy available to improve the lives of so many people on a worldwide basis."
The approval was based on two 24-month randomized, double-masked, placebo-controlled Phase III trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation. The results of the TAP Investigation after 12 months were published in the October 1999 issue of Archives of Ophthalmology, a leading international medical journal. The primary finding of these trials showed that in 243 patients with predominantly classic CNV, vision remained stable or improved in 67 percent of patients treated with Visudyne therapy compared to 39 percent of patients on placebo (p<0.001).
The 24-month results from the TAP Investigation were presented in May at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) and demonstrated that the beneficial effect and the favorable safety profile of Visudyne therapy observed at the 12-month time point have been maintained out to two years. These results also showed that fewer treatments are required in the second year.
"With this effective new therapy now available in the European Union, it is increasingly important to heighten the awareness of this condition among the elderly," said Professor Gisele Soubrane from Creteil Hospital near Paris, France. "Despite the high prevalence of AMD, according to a recent study, only 30 percent of adults are familiar with the condition. We encourage everyone over the age of 50 to see their eye care professional in order to identify their risk of developing AMD and to define their specific follow-up schedule."
Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow under the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision. 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. The drug is then activated by shining non-thermal laser light into the patient's eye.
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.
Related Links: Visudyne (verteporfin), CIBA Vision, Novartis and QLT Inc..
|Health Canada Approves Visudyne (Verteporfin) for Age-Related Macular Degeneration |
MISSISSAUGA, ON, and VANCOUVER, BC -- June 1, 2000 -- CIBA Vision, the eye care unit of Novartis AG, and QLT Inc announced that the Therapeutic Products Programme of Health Canada approved Visudyne (verteporfin for injection) therapy for the treatment of the wet form of age-related macular degeneration (AMD), an eye disease responsible for the majority of blindness in people over the age of 50. Visudyne was discovered by Canadian scientists at Vancouver-based QLT and was subsequently co-developed with CIBA Vision.
An innovative light-activated treatment, Visudyne therapy is specifically indicated for the treatment of AMD patients with predominantly classic subfoveal choroidal neovascularization. Medical experts estimate that of the 500,000 new patients who develop wet AMD every year around the world, 40-60 percent will develop predominantly classic lesions during the progression of their disease. It is also estimated that approximately 20,000 Canadians develop the wet form of AMD each year. Patients with this condition lose their ability to read and recognise faces in as little as two months to three years.
"Visudyne therapy is an important advance in the treatment of AMD. Before today, there was little to offer patients. I am now hopeful that we will be able to preserve and even improve, in some cases, the vision of many of these patients," said Dr. Patricia Harvey, Retina Unit, Vision Science Research Program, Toronto Western Division, University Health Network.
The approval is based on the 12-month results of two 24-month, double-masked, placebo-controlled and randomised studies. The studies included 609 patients from 8 countries including Canada. Results, published in the October 1999 issue of The Archives of Ophthalmology, show that 67 per cent of AMD patients with predominantly classic lesions who were treated with Visudyne therapy lost less than three lines of vision on a standard eye chart compared to 39 per cent on placebo.
The two year results from the studies, announced on March 28 and presented in May at the annual international meeting of the Association for Research in Vision and Ophthalmology, demonstrated that the benefits of Visudyne therapy were maintained over two years.
Roughly twice as many patients on Visudyne lost less than three lines of vision compared to those on placebo. Further, 13 per cent of Visudyne treated patients experienced a vision improvement that was maintained out to two years.
Retreatment rates decreased from 3.4 treatments during the first year to 2.1 treatments during the second year and Visudyne's positive safety profile was maintained. 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.
There are two forms of age-related macular degeneration. The most common is the so-called "dry" form, which is associated with the appearance of small deposits on the macula called "drusen". The macula is a small area of the eye located in the centre of the retina.
Wet AMD is characterised by the formation of abnormal blood vessels (choroidal neovascularization or CNV). These vessels leak fluid and lead to the formation of scar tissue on the macula. Although wet AMD accounts for approximately 15 per cent of all cases of AMD, it is responsible for 90 per cent of vision loss associated with the disease. Wet AMD evolves rapidly and the majority of patients can go blind within a couple of years of being diagnosed.
"It is very gratifying to offer patients a treatment that will be able to improve the quality of their life. Finally, we have an effective and well-tolerated treatment for our patients. This could not have come at a better time as the incidence of AMD is expected to increase sharply as Canadian baby-boomers age," said Dr. Michael Potter, Clinical Assistant Professor, University of British Columbia Medical School, Department of Ophthalmology.
Visudyne can be performed in a doctor's office and consists of two stages.
Visudyne therapy is being co-developed for ocular conditions by CIBA Vision and QLT Inc. CIBA Vision markets the product worldwide while QLT is responsible for manufacturing the product.
QLT Inc. is based in Vancouver, British Columbia. It is a world leader in the development and commercialisation of proprietary pharmaceutical products for use in photodynamic therapy, an emerging field of medicine utilising light-activated drugs in the treatment of disease.
CIBA Vision Canada is headquartered in Mississauga, Ontario and employs 350 people throughout the country. CIBA Vision Corporation, part of Novartis AG, is a global leader in research, development and manufacturing of optical and ophthalmic products and services.
Visudyne is a trademark of Novartis AG.
Related Links: Visudyne (verteporfin), CIBA Vision Canada, QLT Inc. and Novartis AG.
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