US-based Ohr Pharmaceutical has completed patient enrolment in its OHR-002 Phase II clinical trial evaluating Squalamine Eye Drops for treatment of the wet form of age related macular degeneration (wet-AMD).
A total of 142 treatment naive wet-AMD patients at more than 20 clinical sites in the US have been enrolled in the randomised, double masked, placebo controlled Phase II trial.
In the trial, patients are treated with either Squalamine Eye Drops or placebo eye drops twice daily over a nine-month period.
“We are very encouraged by the interest shown by both patients and physicians in this trial and believe our eye drop formulation of Squalamine has the potential to be a valuable new treatment for wet-AMD.”
Ophthalmic Consultants of Boston director of the Vitreoretinal Service, and Ohr member of scientific advisory board Jeffrey Heier said: “A topical therapeutic would offer an important alternative for the large wet-AMD patient population currently being treated with frequent intravitreal injections.”
Primary and secondary endpoints of the trial include visual acuity parameters, need for rescue intravitreal injections, and safety.
Ohr Pharmaceutical chief executive officer Irach Taraporewala said completing enrolment in this Squalamine Eye Drop trial is an important early milestone for the company.
“Additionally, this study serves as the cornerstone of our expanding clinical program to evaluate the efficacy and safety of the Squalamine Eye Drops in multiple ophthalmic disorders currently treated with intravitreal injections.”
The company expects to announce interim data on the first 60 patients completing the protocol in June 2014, while final analysis of all patients is expected in the first quarter of 2015.
The new eye drop formulation of Squalamine is designed for self-administration and may provide several potential advantages over the FDA-approved current standards of care, which require intravitreal injections directly into the eye.
Squalamine used as an intravenous administration in over 250 patients in Phase I and Phase II trials for the treatment of wet-AMD, showed favorable biological effect and maintained and improved visual acuity outcomes.