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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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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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