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news.An advisory panel to the European drug regulator has recommended marketing approval of Macugen, a Pfizer and Eyetech co-developed drug for wet age-related macular degeneration, the leading cause of irreversible severe vision loss in EU patients over 50 years of age.
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Pfizer anticipates the European Commission to grant a marketing authorization by the end of the year. Pfizer will then market the drug exclusively in Europe upon approval. Pfizer and Eyetech co-promote Macugen in the US where the FDA approved the medicine in December 2004.
The drug is the first ophthalmic pharmacological therapy that specifically targets vascular endothelial grown factor (VEGF) 165, a protein that acts as a signal in triggering the abnormal blood vessel growth and leakage that characterize neovascular AMD. Macugen is administered once every six weeks via intravitreal injection.
Age-related macular degeneration (AMD) is an eye disease associated with aging that destroys central vision. An estimated 500,000 people worldwide lose their vision each year from this disease.