Genaera Evizon macular degeneration SPA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genaera plans to begin two identical pivotal trials of Evizon (squalamine) "in the very near future" following a special protocol assessment agreement with FDA, the firm says June 27. The trials will enroll patients with predominantly classic, minimally classic and occult forms of wet age-related macular degeneration. The primary endpoint will be visual acuity at one year; maintenance dosing will continue through two years. Genaera has three Phase II trials of Evizon ongoing. FDA selected the anti-angiogenic agent for its continuous marketing application Pilot 2 program earlier this year; the program provides frequent feedback and interaction with the agency during the IND phase of development (1Pharmaceutical Approvals Monthly January 2005, In Brief)...