http://www.evrs.eu/medias/2006/congress/Increased-Visual-Acuity-in-Fellow-Affected-Eyes-of-Subjects-Undergoing-Therapy-with-Intravenous-EvizonTM-(Squalamine-Lactate)-for-Exudative-AMD.swf

Michael J. Gast, MD, PhD (Plymouth Meeting, PA),* Carl D. Regillo, MD, FACS (Philadelphia, PA), Edgar L. Thomas, MD (Beverly Hills, CA), Charles A. Garcia, MD (Houston, TX), Roger Vogel, MD (Tampa, FL)*

PURPOSE:

High percentages of patients with wet AMD suffer from bilateral disease. We treated subjects with active subfoveal CNV in a study eye with intravenous squalamine in three clinical trials. During these trials visual acuity was also evaluated in fellow eyes affected with AMD. This analysis was performed to evaluate vision change across varying doses of squalamine in affected fellow eyes.

METHODS:

Data from three squalamine monotherapy trials (Studies 106, 207 and 209) was evaluated for both absolute and categorical change in best corrected visual acuity (BCVA). Entry criteria for the trials varied, but active CNV (acute deterioration of visual acuity or presence of subretinal fluid) meeting certain lesion criteria were always required. Fellow eyes had no qualifying criteria, and were designated as affected or non-affected by investigators at the time of baseline evaluation. All subjects were treated with squalamine or vehicle control for at least 4 weeks (depending upon study design) and visual acuity was followed for up to 3 additional months in each trial.

RESULTS:

Fellow affected eye (FAE) responses to squalamine therapy varied by baseline VA and squalamine dose. Mean gains in VA following weekly therapy ranged from 4.4 (Study 209) to almost 10 ETDRS letters (Study 207) in subjects receiving 40 mg of squalamine. Lesser gains were seen in the 20 mg cohorts. In Study 209, 11% of FAEs had a prolonged gain of >15 ETDRS letters in the 40 mg group (compared to 7% in the 20 mg group and 0% of controls). Similar results were seen in the smaller trials. When Study 207 subjects were grouped based on baseline BCVA, a mean gain of 7.4 letters was seen one week following final infusion for subjects with <50 letters of vision at baseline. Similarly, Study 209 subjects receiving 40 mg of squalamine who had a baseline BCVA of <34 letters had a mean gain of 7.8 letters sustained to 24 weeks of therapy, while the 20 mg group gained 5.8 letters and controls gained only 1 letter from baseline.

CONCLUSION:

There is a net vision gain in FAEs of subjects receiving systemic squalamine for exudative AMD. This gain is dose responsive, and particularly marked in subjects with the poorest baseline visual acuity. This positive response to systemic therapy may be of benefit in AMD patients who present with bilateral disease. We will gather more detailed data on FAEs during EVIZON therapy in future trials.
* Financial interest disclosed