Genaera Announces Positive EVIZON Phase II AMD Data At Annual ARVO Meeting

Genaera and study investigators announced recently positive interim clinical trial results, including pharmacokinetic data and visual acuity outcomes, from a multicenter open-label U.S. Phase II clinical trial.

The study is one of a continuing series evaluating EVIZON (squalamine lactate) for the treatment of choroidal neovascularization associated with age-related macular degeneration (AMD), also known as "wet" AMD.

The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting on May 1, 2005, by retinal specialist and study adviser Charles Garcia, M.D., Bernice Weingarten Distinguished Professor of Ophthalmology and Visual Science, University of Texas Health Science Center at Houston.

Dr. Garcia reported interim results from 18 subjects who had received either 10, 20 or 40 mg doses of EVIZON as a part of the trial. All subjects received four weekly doses of intravenous EVIZON with no further maintenance therapy. All but one subject were diagnosed as having wet AMD in both eyes, including early and advanced lesions.

Subjects in the trial were evaluated at various intervals including: week three (after two doses of EVIZON), week five (one week after the fourth dose, termed end-of-therapy), and two and four months after initiation of therapy with EVIZON.

The drug was well tolerated in all subjects. No drug-related systemic adverse events, no drug-related ocular adverse events and no drug-related serious adverse events occurred in subjects involved in the trial. After concluding their participation in this trial, subjects from study 207 were permitted to continue in a twelve-month follow-up study of infusion interval and long-term safety of EVIZON. To date, 14 of the 16 eligible subjects from study 207 have elected to enroll in this trial, which permits monthly infusions of EVIZON on an "as needed" basis.