Posted on the OSN SuperSite August 1, 2008
Othera files investigational new drug application for novel glaucoma therapy
EXTON, Pa. — Othera Pharmaceuticals has submitted an investigational new drug application to the U.S. Food and Drug Administration to conduct a phase 1/2 safety and efficacy trial of an oculoselective beta-blocker for treating glaucoma and ocular hypertension, the company announced.
The novel next-generation topical beta-blocker, called OT-730, is designed to lower IOP. In preclinical animal studies, OT-730 was comparable to timolol maleate in terms of IOP-lowering efficacy and had better systemic safety, according to a press release from the company.
In the multicenter study, patients will be randomly assigned to receive either 0.75% OT-730, 0.5% timolol maleate or placebo.
"We believe that OT-730 may represent a significant advance in terms of patient safety in the treatment of glaucoma," Al Reaves, PhD, Othera's senior vice president of clinical development, said in the release. "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."
The trial is planned for completion later this year, according to the release.
