Othera Initiates Phase I/II Clinical Trial Of OT-730 In Ocular Hypertension And Glaucoma

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 17 Sep 2008 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Othera Pharmaceuticals, Inc., 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.

"We are very excited about the opportunity to bring a product like OT-730 to the glaucoma market," commented David Joseph, Othera CEO and Chairman. "Several new drugs with novel mechanisms of action have recently failed in human clinical trials. It is well-accepted in the ophthalmic community after over 30 years of experience that beta-blockers are successful in lowering IOP. The relative market share of beta-blockers has declined, however, in large part due to safety issues. We have surveyed a number of glaucoma key opinion leaders, and nearly all told us that they would initially prescribe a beta-blocker if it were effective and did not produce the systemic side effects typically seen with this class of drugs. Our compound's unique chemistry enables a clinical development plan emphasizing improved safety, and provides the support needed for OT-730 to be a successful product in a growing, age-related market."

About Glaucoma

Glaucoma is a leading cause of blindness in the world today, affecting more than 65 million people globally. A sight-threatening disease, glaucoma can cause optic nerve damage, visual field loss and even blindness when left untreated. Elevated IOP is considered one of the leading risk factors for glaucoma, and beta-blockers have been successfully used by ophthalmologists for thirty years as first-line or combination therapy with other agents to lower IOP. According to published IMS data, approximately 4 million prescriptions are written in the U.S. each year for ophthalmic beta-blockers, primarily for timolol in a variety of formulations and strengths.

About Othera Pharmaceuticals

Founded in 2002, Othera Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing novel, patient-administered products for ophthalmic disease. In addition to OT-730, Othera is also developing OT-551, a topically-dosed, novel, small molecule that inhibits oxidative stress and disease-induced inflammation. The company has completed enrollment of a Phase 2 clinical trial of OT-551 for the treatment of an advanced form of dry age-related macular degeneration, which is also termed geographic atrophy (GA). Dry AMD affects over 10 million people in the U.S. alone with no approved drug treatments.



Othera Pharmaceuticals