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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.
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August 18, 2014
17:26 EDTOHRPOhr Pharmaceutical reports Q3 EPS (9c), one estimate (10c)
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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.

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