Ohr Pharma Reports Enrollment in First Patient in Phase III Wet AMD Program

Ohr Pharmaceutical, Inc.

, a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that the first patient has been enrolled in the first Phase III clinical trial of its lead drug candidate squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102), for the treatment of neovascular age-related macular degeneration (wet AMD). "The Phase III clinical program will examine the potential of Squalamine, when administered as part of a combination therapy, to significantly improve visual acuity in patients with wet AMD," said Dr. Jason Slakter, CEO of Ohr. "We are focused on successfully executing the trials in an expeditious manner. The Phase III program is designed to provide the data required for regulatory approval in major ophthalmic markets worldwide." The first of two randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada with a target enrollment of 650 treatment naïve subjects with wet AMD. In March 2016, Ohr reached an agreement on a Special Protocol Assessment (SPA) with the U.S Food and Drug Administration (FDA).