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news.US-based Ohr Pharmaceutical has completed patient enrollment in a Phase II clinical trial evaluating Squalamine Eye Drops to treat wet form of age related macular degeneration (wet-AMD).
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The randomized, double masked, placebo controlled Phase II trial has enrolled a total of 142 treatment naive wet-AMD patients at more than 20 clinical sites in the US.
In the trial, patients will be treated with either Squalamine Eye Drops or placebo eye drops twice daily over a nine-month period.
The 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.
"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," Taraporewala said.
"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 intends to release 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.