Othera Pharmaceuticals and the National Eye Institute Commence Dry AMD Study.Phase II Study of OT-551 Eye Drop Enrolls First Patient with Bilateral Geographic Atrophy Associated with Age-Related Macular Degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. EXTON, Pa. -- Othera Pharmaceuticals, Inc. today announced the enrollment of the first patient in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of Othera's topical eye drop OT-551 in patients with Geographic Atrophy (GA), an advanced form of dry Age-Related Macular Degeneration (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ). The study is being conducted at the NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. Medical Center in Bethesda, MD. The study is designed to evaluate OT-551's potential to reduce the loss in central visual acuity visual acuity n. Sharpness of vision, especially as tested with a Snellen chart. Normal visual acuity based on the Snellen chart is 20/20. Visual acuity The ability to distinguish details and shapes of objects. and to slow enlargement of the atrophic area in the macula. OT-551 has high bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. in the eye and distributes to the retina after topical dosing. AMD is the leading cause of blindness in the U.S. in persons over age 55. As many as seven million Americans have early- to intermediate-stage dry AMD, of whom approximately one million have Geographic Atrophy (GA). Persons with GA in both eyes are at greatly elevated risk of progression to potential blindness. The only current therapy for dry AMD is high-dose oral vitamin and zinc supplements, which the NEI NEI National Eye Institute (NIH) NEI Nuclear Energy Institute NEI National Emission Inventory NEI Not Enough Information NEI Netherlands East Indies NEI Nuevos Estados Independientes showed to be modestly effective in slowing progression of intermediate to advanced AMD. This Phase II study will enroll ten patients with bilateral Geographic Atrophy (GA). Patients will receive three daily doses of OT-551 ophthalmic solution over two years. The primary efficacy measure will be change in best-corrected visual acuity. Secondary measures will include: change in area of GA in each eye, as measured by fundus fundus /fun·dus/ (fun´dus) pl. fun´di [L.] the bottom or base of anything; the bottom or base of an organ, or the part of a hollow organ farthest from its mouth. photo grading, progression to advanced neovascular or wet AMD, progression of GA area based on autofluorescence, changes in contrast sensitivity, and change in drusen area. "Geographic Atrophy is an unmet medical need that results in severe and irreversible loss of vision," said Dr. Len Parver, Medical Director of Othera Pharmaceuticals. "An eye drop like OT-551 that could potentially prevent or arrest progression would be a major breakthrough in treating this disease." Othera also announced plans to initiate its own, larger Phase II study in 2007 with OT-551 for geographic atrophy, as well as a study of OT-551 as an adjunctive therapy in the treatment of the wet form of AMD. OT-551 is also currently being tested in Othera's Phase II trial for preventing or slowing the progression of post-vitrectomy nuclear cataract. About Othera Pharmaceuticals Othera Pharmaceuticals, Inc. is a privately-held, specialty pharmaceutical company located in Exton, PA. Othera is developing treatments for the leading causes of blindness and vision impairment in the world, including age-related macular degeneration (AMD), cataracts and glaucoma. Othera's lead compound, OT-551, an eye drop, is being developed to treat several major eye diseases and conditions, including the dry and wet forms of age-related macular degeneration (AMD), cataracts, ocular allergy and dry eye syndrome dry eye syndrome Conjunctivitis arida, keratitis sicca, keratoconjunctivitis sicca, xerophthalmia Medtalk Dryness of eyes, often due to ↓ tear secretion Clinical Dry, greasy, thickened and focally denuded cornea, which may progress to keratomalacia, corneal . Othera's second lead compound, OT-730, is a novel improved beta-blocker for the treatment of glaucoma. More information on Othera Pharmaceuticals is available on the company's website at www.othera.com. |
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