OT-730

Treatment for Glaucoma

IND Application for OT-730

Othera Files IND Application for OT-730 in Glaucoma

EXTON, Pa.--(BUSINESS WIRE)--Jul 30, 2008 - Othera Pharmaceuticals, Inc., announced today 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.

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.

For information please visit Othera's website at www.othera.com.

Contact

Philip Heifetz, 484-879-2805
Othera VP Finance and Business Development
pheifetz@othera.com

Posted: August 2008

OT-730 FDA Approval History

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