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February 20, 2014
09:00 EDTOHRPOhr Pharmaceutical announces positive case report on Squalamine
Ohr Pharmaceutical announced that a case report on the first patient treated in an ongoing investigator sponsored trial with Squalamine eye drops in proliferative diabetic retinopathy was presented at the 37th Annual Macula Society Meeting, in Key Largo, Florida. Diabetic retinopathy is the second most common cause of vision loss. In PDR, abnormal blood vessels grow from the retina into the vitreous cavity of the eye, resulting in blindness if untreated. This ongoing 5 patient OHR-003 trial is designed to determine the efficacy of topical Squalamine Lactate Ophthalmic Solution, 0.2%, in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy. The endpoints include regression of neovascularization, anatomical measurements, visual acuity, and safety parameters.
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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