January 29, 2004.
Source: Novartis AG.
EAST HANOVER, N.J., and VANCOUVER, British Columbia.
Novartis Pharma AG, Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS - News) and QLT Inc. (Nasdaq: QLTI - News; TSX: QLT - News), announced that the Centers for Medicare & Medicaid Services (CMS) has determined the evidence supports reimbursement for patients treated with Visudyne(R) (verteporfin) for age-related macular degeneration (AMD) with occult and minimally classic lesions that are four discs areas or less in size and have evidence of recent disease progression.
Medicare already offers coverage for Ocular Photodynamic Therapy (OPT) in AMD with predominantly classic lesions.
"Age-related macular degeneration is the leading cause of blindness in people over the age of 50, and during the last three years, OPT has helped to reduce the risk of vision loss for tens of thousands of patients. We believe many more will now benefit from the therapy," said Flemming Ornskov, MD, President and Chief Executive Officer of Novartis Ophthalmics Inc.
"This is a significant event for many people who suffer from the occult and minimally classic forms of AMD who presently have no treatment options available to them," said Paul Hastings, President and CEO, QLT Inc.
For a full description of the decision, please refer to http://www.cms.hhs.gov/ncdr/memo.asp?id=101 on the CMS Web site.
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 is 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 (choroidal neovascularization, or 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. Wet AMD is characterized as either "classic" or "occult," depending on the fluorescent pattern of CNV leakage. Approximately 150,000-180,000 new cases of subfoveal wet AMD are diagnosed each year in North America; approximately 40 percent of these cases have the occult (with no classic form) of AMD.
Visudyne, the only drug approved for the treatment of some forms of wet AMD, has been used in more than 300,000 patients worldwide. Visudyne is commercially available in more than 70 countries for the treatment of predominantly classic subfoveal CNV and in more than 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 percent 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.
End of article.
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