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May 9, 2014
08:13 EDTOHRPOhr Pharmaceutical announces initiation of Phase II trial for OHR-005
Ohr Pharmaceutical announced the initiation of a Phase II investigator sponsored clinical trial, OHR-005, testing Squalamine Eye Drops in patients with diabetic macular edema. OHR-005 is a randomized, placebo controlled, investigator sponsored, multicenter Phase II clinical trial evaluating the effect of Squalamine Eye Drops in patients with DME. The primary endpoints will measure change in retinal thickness and change in Best Corrected Visual Acuity over 24 weeks. Secondary objectives include additional BCVA measurements, change in foveal thickness, evaluation of the need for rescue injections of ranibizumab and an assessment of the safety and tolerability of Squalamine Eye Drops.
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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