October 16, 2003.
QLT and Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS) announced that health authorities in Japan have approved Visudyne® (verteporfin) for the treatment of the "wet" form of age- related macular degeneration (AMD), the leading cause of blindness in people over age 50.
Specifically, Visudyne has been approved for the orphan indication of AMD with all types of subfoveal choroidal neovascularization (CNV). Patients with this serious condition lose their ability to read, drive and recognise faces in a few months.
"The approval in Japan is a significant step in our efforts to expand the Visudyne franchise," said Paul Hastings, President and Chief Executive Officer of QLT Inc. "We will now focus our efforts on securing reimbursement to ensure that this treatment is available to the thousands of AMD patients in Japan who previously had no other option due to the lack of any effective means to treat this disease."
Approval was based on the results of a well-designed 12-month clinical study conducted in Japan, which confirmed the efficacy and safety profile of Visudyne as demonstrated in 3 large randomized controlled trials conducted in the rest of the world. In fact, approximately 2 patients out of 3 participating in this study either maintained or improved their vision as a result of Visudyne therapy.
The submission of a new drug application in Japan for Visudyne was made in April 2002. Visudyne was evaluated in Japan as a therapeutic drug for the wet form of AMD following its designation as an orphan drug in June 1997.
"We are thrilled that Visudyne has been approved in Japan," said Flemming Ornskov, MD, MPH, Head, Ophthalmics Business Unit, Novartis. "This is another milestone in our continued efforts to bring Visudyne, the standard of care in AMD treatment, to patients worldwide."
Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light. The process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This, in turn, stops the leakage associated with wet AMD. However, it is important for patients to be diagnosed and treated early if they are to gain maximal benefit from treatment with Visudyne. In Japan, Carl Zeiss Co., Ltd., and Lumenis Japan, Ltd. have submitted approval applications for laser devices, which would be used in Visudyne therapy.
AMD is the leading cause of legal blindness in people over the age of 50. Its associated vision loss has been shown to significantly decrease quality of life. Everyday tasks such as driving and walking can be severely affected. Awareness of the condition and treatment in the initial stages of the disease are essential for patients to take the necessary steps that lead to diagnosis and early treatment to halt progression of AMD.
Vision loss from AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death of the central retina. The wet form is caused by growth of abnormal blood vessels (CNV) under the central part of the retina or macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This results in a deterioration of sight over a period of months to years.
Visudyne is the only drug approved for the treatment of some forms of wet AMD and has been used in more than 250,000 patients worldwide. Visudyne is commercially available in more than 70 countries for the treatment of predominantly classic subfoveal CNV and in over 40 countries for occult subfoveal CNV caused by AMD. It is also approved in more than 55 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases.
Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, back pain, blurring, decreased sharpness and gaps in vision, and in one to five per cent of patients, a substantial decrease in vision with partial recovery. After treatment, patients should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated. For more information visit http://www.visudyne.com.
Visudyne® is a trademark of Novartis AG.
SOURCE: QLT Inc.
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