Genaera Evizon macular degeneration SPA

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)...