Ohr commences Phase II clinical trial of Squalamine for wet-AMD

Ohr PharmaceuticalSep 24 2012

Ohr Pharmaceutical (OTCBB: OHRP-News) today announced 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 patients at twenty one ophthalmology treatment centers across the United States. Interim results are expected in the fourth quarter of 2013.

"An eye drop to treat wet-AMD and ophthalmic neovascular disorders would be transformational for the large patient populations currently taking chronic treatments of Lucentis® or Eylea®, both of which are injected directly into the eye," stated Dr. Irach B. Taraporewala, CEO of Ohr. "In the past few months we have achieved several major milestone events including the completion of a financing at favorable terms as well as the U.S. FDA granting Fast Track designation to our Squalamine Eye Drop program. We are very pleased to announce the initiation of our Phase II trial today which we stated to investors would start by the end of the third quarter."

"I am very excited to be participating in the clinical study of this potentially groundbreaking product," commented Dr. Lawrence Singerman, of Retina Associates of Cleveland, and a member of Ohr's Scientific Advisory Board. "The addition of a self-administered eye drop to treat wet-AMD as an alternative or adjunctive therapy to our current treatment modalities would be a tremendous step forward for patients who suffer from this debilitating condition."

Dr. Michael Elman, investigator at Elman Retina, and a member of Ohr's Scientific Advisory Board, added, "The drug's unique mechanism of action may provide additional clinical advantages well beyond the obvious patient convenience of a self administered eye drop. This could translate into the eye drop's additional use in other retinal disorders which involve neovascularization and affect millions of patients."

Study OHR-002 is a randomized, double blind, placebo controlled Phase II study to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of wet-AMD. The study will enroll 120 treatment naive wet-AMD patients at twenty one clinical sites in the U.S., who 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). More information on the clinical trial can be found at clinicaltrials.gov.