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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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November 16, 2015
08:08 EDTOHRPOhr Pharmaceutical presents new data from OHR-102 Phase II IMPACT study
Ohr Pharmaceutical presented additional positive data from the Phase 2 IMPACT study evaluating OHR-102 combination therapy for the treatment of the wet form of age-related macular degeneration, or wet-AMD. The data were presented by Dr. David S. Boyer, retina specialist at Retina-Vitreous Associates Medical Group and investigator in the study, at the annual meeting of the American Academy of Ophthalmology, or AAO, in Las Vegas. New data from the IMPACT study demonstrates that visual acuity outcomes correlate with the size and composition of lesions in the study patients. Previously, a positive benefit in terms of visual acuity outcomes was shown in patients with classic containing lesions. Detailed analyses of lesion characteristics and their predictive effect on visual acuity outcomes demonstrated that the smaller the occult CNV size, the more pronounced the combination treatment effect on visual acuity, whether or not there was a classic component present. This size effect was not observed in those patients treated with Lucentis monotherapy. The size of occult CNV, irrespective of a classic CNV component, was most important in predicting treatment success with the combination of OHR-102 plus Lucentis. In those patients with occult CNV less than 10mm2 in area, 40% of those treated with the combination of OHR-102 plus Lucentis achieved a gain of 3 or more lines of vision, compared with 26% of patients in the Lucentis monotherapy arm, a 54% additional benefit. In addition, mean gains in visual acuity compared to baseline were +11.0 letters for the OHR-102 plus Lucentis combination arm and +5.7 letters with Lucentis monotherapy, a clinically meaningful benefit of +5.3 letters. Importantly, this group of patients represents a larger proportion of the subjects enrolled in the IMPACT study than the classic containing group.
November 13, 2015
08:22 EDTOHRPAmerican Academy of Ophthalmology to hold annual meeting
AAO 2015 is being held in Las Vegas, Nevada on November 13-17 with webcasted presentations to begin on November 13 at 11:50 am. Webcast Link
November 12, 2015
09:21 EDTOHRPOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 5.4%... NetEase (NTES), up 6.3%... SunPower (SPWR), up 3.4%. ALSO HIGHER: Angie's List (ANGI), up 12.1% after after IAC (IAC) proposes to acquire the company... OHR Pharmaceutical (OHRP), up 7.4% after submitting a Special Protocol Assessment request to the FDA for OHR-102... Galena Biopharma (GALE) up 6.2% after being upgraded to Outperform from Perform at Oppenheimer... MannKind (MNKD), up 5.4% after confirming a planned stock sale. DOWN AFTER EARNINGS: Freshpet (FRPT), down 25%... Advance Auto Parts (AAP), down 11.1%... Viacom (VIAB), down marginally. ALSO LOWER: Derma Sciences (DSCI), down 30.4% after ending its Phase 3 clinical trials with aclerastide, DSC127, for diabetic foot ulcer healing... Sunedison (SUNE), down 11.2% after being downgraded to Sell from Neutral at Axiom.
08:08 EDTOHRPOhr Pharmaceutical announces submission of SPA request for OHR-102
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