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June 24, 2014
07:03 EDTOHRPOhr announces positive interim Phase II results of Squalamine eye drops
Ohr Pharmaceutical announced positive top-line interim results for its double-masked, placebo-controlled Phase II clinical trial of Squalamine eye drops in patients with wet age-related macular degeneration. The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of plus 10.4 letters with Squalamine eye drops plus Lucentis PRN versus plus 6.3 letters in the placebo eye drops plus Lucentis PRN arm. The visual acuity improvements were seen as early as four weeks and the relative difference in visual acuity between the two treatment arms continued to increase throughout the study. In the interim analysis, there were no significant differences in the frequency of Lucentis PRN injections, which was the primary endpoint of the study. The company plans to present the full data from this interim analysis at an ophthalmology conference in the 2H14, with final clinical trial data expected in the 1Q15.
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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