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Age Related Macular Degeneration
Company completes SPA with FDA for EVIZON in AMD
July 25th, 2005
Genaera Corp. (GENR) announced that it has reached agreement on a special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of two global registration phase III clinical trials evaluating EVIZON (squalamine lactate) for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as "wet" AMD. This SPA is a binding written agreement between Genaera and the FDA that the clinical protocols for the planned phase III trials are adequate to meet scientific and regulatory requirements to form the primary basis for efficacy claims in a new drug application for EVIZON. ...
Source: Health & Medicine Week (2005-07-25)
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