OHR Pharmaceutical Inc (NASDAQ:OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that it has reached an agreement on the Special Protocol Assessment (SPA) with the United States Food and Drug Administration (US FDA) on the design of the Phase III trial for its lead drug candidate, squalamine lactate ophthalmic solution, 0.2% (“Squalamine,” also known as OHR-102).  Based on the agreed upon SPA, Ohr has initiated the first of two planned Phase III global clinical studies evaluating the efficacy and safety of Squalamine, given in combination with Lucentis®, for the treatment of neovascular age-related macular degeneration (wet AMD).

“We are extremely pleased to have completed the SPA process. This agreement with the FDA enables us to move forward with the Squalamine Phase III clinical program,” commented Dr. Jason Slakter, CEO of Ohr. “The initiation of our Phase III clinical program is a monumental achievement for the company and represents an important step in our mission to develop and commercialize therapeutics for unmet medical needs in ophthalmology.”

“This is fantastic news for the retinal community and the patients in our care,” said Dr. David S. Boyer, retina specialist at Retina-Vitreous Associates Medical Group, Beverly Hills, CA, and a member of Ohr’s Scientific Advisory Board. “Based on my clinical experience, Squalamine is a promising drug with the potential to non-invasively improve visual function over the current standard of care. I look forward to the opportunity to enroll patients in this important clinical study.”

Dr. Avner Ingerman, Ohr’s Chief Clinical Officer, added, “We are working with the retinal community and Ohr’s Scientific Advisory Board to expeditiously implement a high-quality Phase III clinical development program to fully support future regulatory applications.”

The first of two randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada and is expected to enroll approximately 650 treatment naïve subjects with wet AMD. The primary efficacy endpoint of the clinical trial is the change in visual function at nine months. (Original Source)

Shares of OHR Pharmaceutical closed yesterday at $2.85, up $2.85 or 2.85%. OHRP has a 1-year high of $6.56 and a 1-year low of $2.02. The stock’s 50-day moving average is $3.19 and its 200-day moving average is $3.65.

On the ratings front, OHRP has been the subject of a number of recent research reports. In a report issued on February 10, Brean Murray Carret analyst Jonathan Aschoff maintained a Buy rating on OHRP, with a price target of $30, which implies an upside of 952.6% from current levels. Separately, on December 10, Roth Capital’s Elemer Piros reiterated a Buy rating on the stock and has a price target of $30.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Elemer Piros have a total average return of -13.8% and -31.0% respectively. Aschoff has a success rate of 31.2% and is ranked #3729 out of 3749 analysts, while Piros has a success rate of 20.5% and is ranked #3713.

Ohr Pharmaceutical Inc is a pharmaceutical company engaged in the development of the Company’s previously acquired compounds.