Industry News — Clinical Updates
Ohr Pharmaceutical Completes Enrollment for Phase II Clinical Trial of Squalamine Eye Drops for Treating Wet AMD
Ohr Pharmaceutical, Inc. (New York, NY) announced that it has completed enrollment for its OHR-002 Phase II clinical trial, Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (AMD). Squalamine is an anti-angiogenic small molecule with a novel intracellular mechanism of action, which counteracts multiple growth factors implicated in the angiogenesis process.
Ohr enrolled 142 treatment-naive wet-AMD patients at more than 20 clinical sites in the US. Patients will be treated with Squalamine eye drops or placebo eye drops twice daily over a 9-month period. The primary and secondary endpoints include:
- Visual acuity parameters
- Need for rescue intravitreal injections
- Safety
The protocol includes an interim analysis based on the first 60 patients completing the treatment period. Ohr plans to announce the interim data on these patients in June 2014. Final data are expected in the first quarter of 2015.
In more than 250 wet-AMD patients in phase I and II trials, Squalamine has showed favorable biological effects and maintained and improved visual acuity (VA) outcomes. In May 2012, the Squalamine Eye Drop program was granted Fast Track designation by the US Food and Drug Administration (FDA).
Two additional investigator-sponsored trials (IST) are evaluating Squalamine eye drops for the treatment of proliferative diabetic retinopathy and retinal vein occlusion (RVO), and 2 additional ISTs are expected to be initiated for diabetic macular edema (DME) in the second quarter of 2014.
Updated May 1, 2014