NEW YORK, Oct. 7, 2014 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, announced today that additional positive anatomic and visual acuity data from the IMPACT study, a phase II clinical trial evaluating Squalamine eye drops (OHR-102) for the treatment of the wet form of age-related macular degeneration (wet AMD), will be presented in two separate podium sessions at the 2014 American Academy of Ophthalmology (AAO) Annual Scientific Meeting, being held in Chicago, Illinois, from October 17-21, 2014.
|Title:||"Squalamine Eye Drops for Retinal Disease"|
|Date:||Friday, October 17, 4:59p.m. Central Time|
|Session:||Section VIII- Neovascular AMD|
|Presenter:||Thomas A. Ciulla, MD|
|Midwest Eye Institute|
|Clinical Investigator in the IMPACT Study|
Dr. Ciulla will discuss additional positive top-line data and subset analysis from the interim results of the IMPACT study. The IMPACT study is a phase II study designed to determine if OHR-102 (Squalamine eye drops) administered in combination with Lucentis® PRN can safely improve visual outcomes compared to Lucentis monotherapy in patients with treatment naïve neovascular AMD. Dr. Ciulla's presentation includes data showing topical administration of OHR-102 used in combination with Lucentis demonstrated marked improvements over Lucentis monotherapy in multiple visual acuity parameters in the IMPACT study.
|Title:||"Interim Phase 2 Results of Squalamine Lactate Ophthalmic Solution 0.2% (OHR -102) in Neovascular Age-Related Macular Degeneration"|
|Date:||Saturday, October 18, 10:33a.m. Central Time|
|Session:||Section XI- Late Breaking Developments, Part III|
|Presenter:||David S. Boyer, MD|
|Retina-Vitreous Associates Medical Group, Beverly Hills, CA|
|Clinical Investigator in the IMPACT Study|
Dr. Boyer's presentation will include new data on the anatomic analysis and findings seen in the interim dataset from the phase II IMPACT study in wet-AMD, including data on a potential biomarker for neovascular disease regression and its relationship to visual improvements seen in the study.
About Squalamine Eye Drops (OHR-102)
Squalamine is an anti-angiogenic small molecule with a novel intracellular mechanism of action, which counteracts multiple growth factors and pathways implicated in the angiogenic process, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and basic fibroblast growth factor (bFGF). Ohr Pharmaceutical has developed a novel eye drop formulation of Squalamine (OHR-102) for the treatment of wet AMD, designed for convenient, patient self-administration, which may provide clinical utility for this patient population and other back-of-the-eye disorders. In May 2012, the Squalamine eye drop program was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). A Phase II randomized, double masked, placebo-controlled study (IMPACT Study) to evaluate the efficacy and safety of Squalamine eye drops for the treatment of wet AMD is ongoing and has completed enrollment. Interim data released in June 2014 demonstrated benefit in visual function versus placebo across multiple standard parameters. Three additional investigator sponsored trials (IST) are evaluating Squalamine eye drops for the treatment of proliferative diabetic retinopathy, retinal vein occlusion, and diabetic macular edema.
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 www.ohrpharmaceutical.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA or Health Canada will approve final testing or marketing of any pharmaceutical product. Ohr's most recent Annual Report and subsequent Quarterly Reports discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.
Lucentis® is a registered trademark of Genentech, Inc.
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