Squalamine lactate

Ohr Pharmaceutical Announces Efficacy Results from the MAKO Study in Wet-AMD Details Category: Small Molecules Published on Friday, 05 January 2018 13:42 Hits: 1395 NEW YORK, NY, USA I January 05, 2018 I Ohr Pharmaceutical, Inc. (NASDAQ:OHRP), a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases, today reported topline data from the MAKO study which did not meet its primary efficacy endpoint. The MAKO study evaluated the efficacy and safety of topically administered squalamine in combination with monthly Lucentis® injections for the treatment of wet age-related macular degeneration (“wet-AMD”). The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis. Subjects receiving squalamine combination therapy (n=119) achieved a mean gain of 8.33 letters from baseline versus 10.58 letters from baseline with Lucentis® monotherapy (n=118). There were no differences in the safety profile between the two treatment groups. “We are very disappointed with the outcome of the MAKO study,” commented Dr. Jason Slakter, chief executive officer of Ohr. “We are grateful to the patients and physicians who participated in the clinical trial. Based on these results, we intend to evaluate strategic alternatives to maximize shareholder value.” About the MAKO Study The MAKO study was a multi-center, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of squalamine combination therapy for the treatment of wet-AMD. Subjects were randomized 1:1 to receive topical squalamine lactate ophthalmic solution, 0.2%, (“squalamine”) twice daily (“BID”) and monthly Lucentis® injections (“squalamine combination”) or topical placebo BID and monthly Lucentis® injections (“Lucentis monotherapy”). Eligibility criteria for the study eye included: newly diagnosed with wet-AMD and no previous treatment, occult neovascularization, if present, measured less than 10mm2 as assessed by fluorescein angiography, and visual acuity between 20/40 and 20/320. A total of 237 subjects were randomized. Visual acuity was measured monthly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart. The primary efficacy endpoint was the mean visual acuity gain at nine months, using a mixed-effects model for repeated measures (MMRM) analysis. About Ohr Pharmaceutical, Inc. Ohr Pharmaceutical, Inc. (OHRP) is a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases. The company has completed two clinical trials with squalamine lactate ophthalmic solution, 0.2%, for the treatment of the wet form of age-related macular degeneration. In addition, Ohr has a sustained-release micro-fabricated micro-particle ocular drug delivery platform technology. SOURCE: Ohr Pharmaceuticals

NEW YORK, Dec. 2, 2014 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced that Dr. Irach Taraporewala, Chief Executive Officer, will present a corporate overview and business update at the Oppenheimer & Co., Inc.'s 25th Annual Healthcare Conference, being held at the Crowne Plaza Hotel in New York City on December 10-11, 2014. Details of the presentation: Date: Thursday, December 11 Time: 3:20pm Eastern Webcast: About Ohr Pharmaceutical, Inc. Ohr Pharmaceutical, Inc. (OHRP) is an ophthalmology research and development company. The company's lead product, Squalamine, is currently being studied as an eye drop formulation in several company sponsored and investigator sponsored Phase II clinical trials for various back-of-the-eye diseases, including the wet form of age-related macular degeneration, retinal vein occlusion, diabetic macular edema, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. The lead sustained release program in glaucoma is proceeding under a collaboration with a large global pharmaceutical company. Additional information on the company may be found at . CONTACT: Ohr Pharmaceutical Inc. Investor Relations 888-388-2327 ir@ohrpharmaceutical.com LifeSci Advisors, LLC Michael Wood 646-597-6983 mwood@lifesciadvisors.com Help employers find you! Check out all the jobs and post your resume.