Ohr Pharmaceutical Launches Clinical Trial to Evaluate Squalamine Eye Drops for Wet AMD
October 17, 2012
After completing a long term safety study of Squalamine Eye Drops indicating that the eye drop is safe when applied to the eye, Ohr Pharmaceutical (OTCBB: OHRP) announced late last month the initiation of a Phase II clinical trial to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration (“wet AMD”).
The randomized, double blind, placebo controlled study will enroll 120 patients suffering from wet AMD at twenty one clinical sites in the U.S. They will be treated with Squalamine Eye Drops twice daily for a nine month period. The primary and secondary endpoints include visual acuity parameters, need for rescue intravitreal injections, and safety. The protocol includes an interim analysis upon the completion of the treatment period in 50% of the patients (approximately 60).
Clearly, an eye drop to treat wet-AMD and ophthalmic neovascular disorders would be transformational for the large patient populations currently receiving injections of Lucentis® or Eylea®.
The FDA has granted Fast Track designation to the Squalamine Eye Drop program.
Click here for further details.
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