NOVARTIS AG: QLT INC - Novartis Ophthalmics and QLT File Submission With the European - Medicines Evaluation Agency to Expand the Use of Visudyne(TM) in AMD
Toronto, Ontario, Sep 07, 2001 (Market News Publishing via COMTEX) -- Novartis Ophthalmics, the eye health unit of Novartis AG and QLT Inc. announced the filing of Visudyne(TM) (verteporfin) therapy with the European Medicines Evaluation Agency (EMEA) for marketing clearance in the European Union (EU) for the treatment of occult subfoveal choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (AMD). AMD is the leading cause of blindness in people over the age of 50.
This submission is based on favorable two-year results from a phase III clinical trial showing Visudyne has a significant treatment benefit in AMD patients with occult CNV. The results were published in the May 2001 issue of the peer-reviewed American Journal of Ophthalmology.
Luzi von Bidder, head of Novartis Ophthalmics, said, "We look forward to the European agency's assessment of this important therapy and the potential benefit to the many patients who suffer from this devastating condition for which there is currently no approved drug treatment available."
"This EU submission is a very important milestone," said Dr. Julia Levy, president and CEO of QLT. "Occult CNV represents a considerable portion of the total wet AMD population and if approved this indication could significantly expand the current market for Visudyne."
Visudyne is commercially available in 50 countries for the treatment of predominantly classic subfoveal CNV caused by AMD. It is also approved in over 20 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In the U.S., Visudyne has received an additional approval for CNV due to presumed ocular histoplasmosis. Approximately 80,000 patients have undergone Visudyne therapy worldwide. In May, Visudyne was awarded the prestigious Prix Galien for therapeutic
innovation in France, Belgium and Portugal.
Occult and classic are terms used to describe different patterns of CNV leakage as seen on fluorescein angiography. Together, the occult and predominantly classic forms of the disease account for approximately two-thirds of all wet AMD cases at diagnosis. Annually, it is estimated that 500,000 new patients develop wet AMD worldwide.
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