Ohr Reports Successful End Of Phase II Meeting With FDA On OHR-102 In Wet AMD

(RTTNews) - Ohr Pharmaceutical Inc. (OHRP) announced details of the planned pivotal Phase III registration trials for Squalamine Eye Drops (OHR-102) in the treatment of wet age-related macular degeneration or wet AMD. The trials are being designed based on guidance provided by the U.S. Food and Drug Administration or FDA at a recent "end of Phase II" meeting.

The company noted that the FDA has agreed with Ohr on a 9 month primary efficacy endpoint based on the proportion of patients achieving a >=3 line gain in visual acuity.

In the interim analysis of the ongoing Phase II IMPACT study, more than twice the proportion of patients achieved >=3 line gains in visual acuity at 9 months with the combination of OHR-102 eye drops and Lucentis(R) as compared to the Lucentis monotherapy group (overall p=0.025, classic lesions p=0.007). Two identical Phase III studies will be performed.

The company noted that it plans to initiate the Phase III trials in the first half of 2015 with the goal of submitting a New Drug Application or NDA following collection and analysis of the 9 month primary efficacy data.

The Phase III trials for Squalamine eye drops are being designed to measure the efficacy of combination therapy with OHR-102 eye drops plus Lucentis injections compared with Lucentis monotherapy at 9 months. All patients will be followed for safety for 2 years. The primary endpoint will be a measure of improvement in visual acuity, as defined by the proportion of patients achieving gains of >=3 lines or more on the early treatment diabetic retinopathy study chart.

During the first year of the study, patients will be randomized 1:1 to receive monthly Lucentis plus OHR-102 (Squalamine eye drops) twice a day or Lucentis plus placebo. During the second year they will receive Lucentis PRN (as needed) plus OHR-102 or placebo twice a day.