Othera Initiates Phase I/II Clinical Trial of OT-730 in Ocular Hypertension and Glaucoma
News Sep 16, 2008
Othera Pharmaceuticals, Inc. has announced that it has initiated dosing in a Phase I/II clinical trial to determine the safety and efficacy of topical OT-730 in patients with ocular hypertension and glaucoma.
The study is a randomized, multi-center, investigator-masked, timolol- and placebo-controlled evaluation of the safety and efficacy of OT-730 in reducing the intraocular pressure in subjects with ocular hypertension or open-angle glaucoma. Subjects will be randomized to one of 0.75% OT-730, 0.5% timolol maleate or placebo.
Differentiation in the glaucoma market for OT-730 derives from an enhanced safety profile within a well-accepted class of marketed drugs. OT-730 is a novel, internally developed next generation topical beta-blocker designed to lower intra-ocular pressure (IOP), the leading risk factor for developing glaucoma.
Beta-blockers as a class are among the most widely-prescribed drugs for glaucoma, but carry label warnings regarding the potential for serious systemic side effects.
In preclinical animal studies, OT-730 demonstrated comparable IOP-lowering efficacy and superior systemic safety to the most-prescribed ocular beta-blocker, timolol maleate. OT-730 is by design an oculoselective drug, having excellent beta-blocking activity in the eye, yet easily metabolized into inert components upon entry into the bloodstream.