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August 13, 2014
08:35 EDTOHRPOhr Pharmaceutical announces additional phase II data from IMPACT study
Ohr Pharmaceutical announced additional interim data from the Phase II study evaluating Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration. The data demonstrated a visual acuity and anatomical benefit for the group of patients receiving the combination of OHR-102 and Lucentis PRN versus placebo eye drops plus Lucentis PRN. Jason Slakter, MD, Chief Medical Officer at Ohr, presented the data on Tuesday, August 12 at the 2014 Annual Meeting of the American Society of Retina Specialists. New data presented at ASRS showed that mean change in central subfield thickness was -139Ám in the OHR-102 arm versus -117Ám in the Lucentis monotherapy arm. Representative cases were shown at ASRS demonstrating that the combination of OHR-102 and Lucentis resulted in the resolution of sub-retinal hyper reflective material as well as intra-retinal and subretinal edema. There were no significant differences in the frequency of Lucentis PRN injections, which was the primary endpoint of the exploratory Phase II study. As announced previously, the mean number of Lucentis injections was 6.2 for the OHR-102 arm and 6.4 for the Lucentis monotherapy arm, which included the baseline injection and any injections required up to and including the final study visit for the interim analysis group. Squalamine eye drops were well tolerated and had a comparable safety profile to Lucentis monotherapy arm.
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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