Occlusions

August 3, 2015

Ohr Pharmaceutical released results of a phase II trial of OHR-102 (0.2% Squalamine lactate ophthalmic solution) plus Lucentis in patients with macular edema secondary to branch (BRVO) and central retinal vein occlusion (CRVO). The 38-week, investigator-sponsored trial enrolled 20 treatment naïve patients with macular edema due to retinal vein occlusion. All patients received OHR-102 topically for the first 10 weeks of treatment, with two injections of Lucentis given at week two and week six. The results demonstrated that, following an initial 10 week combination therapy treatment period, patients who continued to receive a combination of topical OHR-102 BID plus Lucentis achieved greater visual acuity gains than the control group who received Lucentis alone. At week 38, the mean gain in visual acuity from baseline for patients randomized (at week 10) to treatment with OHR-102 plus Lucentis PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis plus PRN alone (control group), a clinically meaningful difference of +4.5 letters. At week 38, 80% of patients in the OHR-102 plus Lucentis treated group had a gain in visual acuity, compared with 50% of patients treated with Lucentis alone. Additionally, at week 38, none of the patients in the OHR-102 plus Lucentis treated group lost any vision. Patients treated with OHR-102 plus Lucentis PRN required a mean of two Lucentis injections between weeks 10 and 38, compared with a mean of 3.3 Lucentis injections for the monotherapy group over the same time period.

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