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News Breaks
May 16, 2014
05:29 EDTOHRPOhr Pharmaceutical has replay of conference call
Conference call which discussed agreement to acquire technology assets of SKS Ocular was held on May 15 at 5 pm. Webcast Link
News For OHRP From The Last 14 Days
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October 20, 2014
07:25 EDTOHRPOhr Pharmaceutical announces positive data on OHR-102 IMPACT study
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October 14, 2014
07:19 EDTOHRPOhr 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.

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