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www.fdanews.com/articles/67107-study-shows-macugen-effectively-treats-neovascular-age-related-macular-degeneration

STUDY SHOWS MACUGEN EFFECTIVELY TREATS NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

January 3, 2005

Study results published in the Dec. 30, 2004, issue of The New England Journal of Medicine show that the drug Macugen is an effective and well-tolerated treatment for neovascular, or "wet," age-related macular degeneration (AMD).

Macugen (pegaptanib sodium injection), the first in a new class of ophthalmic drugs known as vascular endothelial growth factor inhibitors, is the first proven anti-angiogenic treatment in ophthalmology and benefits patients with all subtypes and sizes of neovascular AMD.

On Dec. 17, 2004, the FDA approved Macugen for the treatment of neovascular AMD. Until then, the only FDA-approved treatment was for the predominantly classic subtype of neovascular AMD, which afflicts up to 25 percent of the patient population. The study, called the VEGF Inhibition Study in Ocular Neovascularization, showed that among patients receiving 0.3 mg Macugen, 70 percent lost less than three lines of vision on the study eye chart after 54 weeks, compared with 55 percent of patients in the control group.

Further analysis showed that the results were consistent regardless of disease subtype and lesion size and Macugen reduced the risk of progression to legal blindness in the treated eye by half at the end of one year.