Ohr Pharmaceutical, Inc. announced phase 2 clinical data supporting the use of squalamine eye drops for macular edema secondary to branch (BRVO) or central retinal vein occlusion (CRVO).
The data demonstrated that squalamine combined with intravitreal ranibizumab led to a mean gain in visual acuity of 20.3 letters and resolution of the fovial edema in 95% of the patients at week 10.
"The early effect on visual acuity, edema, and percentage of early responders appears to be better than those seen in historical monthly Lucentis retinal vein occlusion trials,” said John Wroblewski, MD, retina specialist at Cumberland Valley Retina Consultants, who presented the data at the 2014 Annual Meeting of the American Society of Retina Specialists on Saturday. “I look forward to the completion of the extension stage of the study and presenting those results in the first quarter of 2015."
Squalamine is an anti-angiogenic small molecule with a novel intracellular mechanism of action that counteracts multiple growth factors and pathways implicated in the angiogenic process, including vascular endothelial growth factor, platelet-derived growth factor, and basic fibroblast growth factor.
This prospective, single site, investigator-sponsored trial included 20 treatment naïve patients with macular edema due to non-ischemic CRVO, BRVO or hemi-central RVO (HRVO). All 20 patients received squalamine for the first ten weeks of treatment, with two injections of Lucentis given at week two and week six.
At week 10, the average letter gain was 18.2 for CRVO, 18.1 for BRVO, and 32.3 for HRVO. In addition, 80% of patients achieved gains of ≥3 lines, with 40% of achieving gains of ≥4 lines. Overall, mean Snellen visual acuity at week 10 was 20/32 for all groups and there was a mean improvement in central fovial thickness on optical coherence tomography from 723 to 270 microns.
In the extension stage of the study, patients were randomized 1:1 at week 10 to either continue squalamine twice a day or discontinue drops for the remainder of the 38-week study with ranibizumab administered as needed based on OCT retreatment criteria.