Othera Files IND Application for OT-730 in Glaucoma

Novel Treatment Promises Improved Safety over Existing Therapies

04-Aug-2008

Othera Pharmaceuticals, Inc., announced the submission of an Investigational New Drug (IND) application to the U.S. food and Drug Administration (FDA) for OT-730, an oculoselective beta-blocker, as a potential treatment for glaucoma. A Phase 1-2 safety and efficacy trial is planned for completion by the end of 2008.

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.

"We believe that OT-730 may represent a significant advance in terms of patient safety in the treatment of glaucoma" commented Dr. Al Reaves, Sr. VP of Clinical Development. "All of the current drug therapies for glaucoma on the market today have side effects, some potentially life-threatening. OT-730 has been specifically designed as a prodrug to deliver a potent beta-blocker locally within the eye, but then rapidly break down to inactive metabolites upon entry into the systemic circulation. Our goal in clinical trials will be to compare its IOP-lowering effect against timolol (the most-prescribed ocular beta-blocker) and to determine its effects, if any, on cardiovascular and pulmonary function. We believe that OT-730's unique safety profile could ultimately position it as a leading monotherapy or in combination with other classes of drugs for use in glaucoma patients."

The study is a randomized, multi-center, investigator-masked, timolol- and placebo-controlled, Phase 1-2 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.

https://www.bionity.com/en/news/85362/othera-files-ind-application-for-ot-730-in-glaucoma.html