NEW YORK, Aug. 7, 2014 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced that data from clinical studies evaluating Squalamine eye drops for the treatment of macular edema secondary to central and branch retinal vein occlusion, and the wet form of age-related macular degeneration (wet AMD), will be presented in two separate sessions at the 2014 Annual Meeting of the American Society of Retina Specialists, being held at the Hilton Bayfront Hotel in San Diego, California.
| Date: || Saturday, August 9, 10:33 a.m. Pacific Time |
| Session: || Retinal Vascular Disease |
| Presenter: || John Wroblewski, MD |
| || Cumberland Valley Retina Consultants, Hagerstown, Maryland |
| Title: || "Open-Label Squalamine Lactate Ophthalmic Solution for the Treatment of Macula Edema Secondary to Branch and Central Retinal Vein Occlusion" |
Dr. Wroblewski will discuss top-line data from Stage 1 of the 2-stage study. The study was designed to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of macular edema secondary to branch and central retinal vein occlusion. In Stage 1 of the study, all 20 patients received Squalamine Eye Drops for the first 10 weeks of treatment, with two mandatory injections of Lucentis® given at week 2 and week 6. In Stage 2 of the study, patients are being randomized 1:1 at week 10 to either continue administering Squalamine Eye Drops or discontinue drops for the remainder of the 38-week study. Rescue injections of Lucentis will be administered as needed through week 38 based on OCT criteria. The primary and secondary endpoints include visual acuity parameters, need for rescue retreatments, retinal thickness, vascular leakage and change in area of non-perfusion.
| Date: || Tuesday, August 12, 2:32 p.m. Pacific Time |
| Session: || AMD Neovascular 2 |
| Presenter: || Jason Slakter, MD |
| || Chief Medical Officer, Ohr Pharmaceutical, Inc. |
| Title: || "Interim Results From a Phase 2 Study of Squalamine Lactate Ophthalmic Solution 0.2% in the Treatment of Neovascular Age-Related Macular Degeneration" |
Dr. Slakter will discuss additional top-line data and other subset analyses of the interim results from the Phase 2 study of Squalamine in wet age-related macular degeneration (wet AMD) from those announced in June this year. The interim analysis was conducted on the first 62 patients (29 treated in the Squalamine arm, 33 treated in the placebo arm), who completed the entire nine months of the treatment protocol (representing approximately 50% of the targeted study population). The ongoing trial is a randomized, double-masked, placebo-controlled Phase II study to evaluate the efficacy and safety of Squalamine eye drops used in combination with Lucentis PRN for the treatment of wet AMD. The trial has enrolled a total of 142 newly diagnosed, treatment naïve patients. Patients received an initial intravitreal injection of Lucentis at study entry, and then underwent a 1:1 randomization to receive a daily dose of either Squalamine eye drops or placebo eye drops administered twice daily for nine months. Patients had monthly follow-up clinic visits, where they were evaluated and retreated as needed with Lucentis if pre-specified clinical criteria were met. The primary endpoint was the mean number of Lucentis injections and secondary endpoints included visual acuity as well as diagnostic imaging outcomes.
About Squalamine Eye Drops
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 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 (OHR-002) 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. CONTACT: CORPORATE CONTACT: Ohr Pharmaceutical Inc. Investor Relations 888-388-2327 firstname.lastname@example.org LifeSci Advisors, LLC Michael Rice 646-597-6979 email@example.com
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