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news.Othera Pharmaceuticals has submitted an investigational new drug application to the FDA for OT-730, an oculoselective beta-blocker, as a potential treatment for glaucoma.
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A Phase I-II safety and efficacy trial is planned for completion by the end of 2008. This study is a randomized, multi-center, investigator-masked, timolol- and placebo-controlled, Phase I-II evaluation of the safety and efficacy of OT-730 ophthalmic solution in reducing the intraocular pressure in subjects with ocular hypertension or open-angle glaucoma. Subjects will be randomized to placebo or 0.5% timolol maleate or 0.75% OT-730.
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.
Al Reaves, senior vice president of clinical development at Othera, said: “We believe that OT-730 may represent a significant advance in terms of patient safety in the treatment of glaucoma. Our goal in clinical trials will be to compare its intra-ocular pressure-lowering effect against timolol and to determine its effects, if any, on cardiovascular and pulmonary function.”