Ohr Pharmaceutical to discuss Squalamine Phase II data on conference call Ohr Pharmaceutical announced that it will host a conference call and webcast on Tuesday, June 24th to discuss Squalamine interim Phase II data in wet age-related macular degeneration, wet-AMD. Shares of Ohr Pharmaceutical are up almost 7% after hours after ending the regular trading session up almost 17%.
Ohr Pharmaceutical announces successful end of Phase II meeting with FDA Ohr Pharmaceutical announced details of the planned pivotal Phase III registration trials for Squalamine Eye Drops, or 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 FDA at a recent "end of Phase II" meeting. The FDA has agreed with Ohr on a 9 month primary efficacy endpoint based on the proportion of patients achieving a greater than or equal to 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 greater than or equal to 3 line gains in visual acuity at 9 months with the combination of OHR-102 eye drops and Lucentis as compared to the Lucentis monotherapy group. Two identical Phase III studies will be performed. The company plans to initiate the Phase III trials in the first half of 2015 with the goal of submitting a New Drug Application following collection and analysis of the 9 month primary efficacy data.