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Novartis seeks expanded approval in Europe for Visudyne

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BULACH, Switzerland — Novartis Ophthalmics and QLT Inc. are seeking approval from the European Medicines Evaluation Agency (EMEA) for Visudyne (verteporfin for injection) therapy for the treatment of occult subfoveal choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (AMD). Visudyne is already approved in 50 countries, including the countries of the European Union, for the treatment of predominantly classic subfoveal CNV caused by AMD.

The submission is based on favorable 2-year results from a phase 3 clinical trial. The results of the study were published in a recent issue of the American Journal of Ophthalmology.

Visudyne has been approved in more than 20 countries for the treatment of subfoveal CNV due to pathologic myopia. In the United States, Visudyne has also received marketing approval for the treatment of CNV due to presumed ocular histoplasmosis. In May, Visudyne was awarded the Prix Galien for therapeutic innovation in France, Belgium and Portugal.