Othera begins phase I/II trial

November 1, 2008

Othera Pharmaceuticals Inc. has begun dosing in a phase I/II multicenter, investigator-masked clinical trial of the safety and efficacy of a topical drug (OT-730) in reducing IOP in subjects with ocular hypertension or open-angle glaucoma.

Key Points

Exton, PA-Othera Pharmaceuticals Inc. has begun dosing in a phase I/II multicenter, investigator-masked clinical trial of the safety and efficacy of a topical drug (OT-730) in reducing IOP in subjects with ocular hypertension or open-angle glaucoma. Subjects will be assigned randomly to receive the 0.75% formulation of the investigational drug, 0.5% timolol maleate, or placebo.

The drug being studied is a novel, next-generation, topical, beta-blocker designed to lower IOP. In preclinical animal studies, it demonstrated comparable IOP-lowering efficacy and superior systemic safety versus the most-prescribed ocular beta-blocker, timolol maleate, according to the company. By design, the medication is an oculoselective drug that offers beta-blocking activity in the eye while being metabolized easily into inert components on entry into the bloodstream, according to the company.

"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," said David Joseph, Othera chief executive officer and chairman. "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 [the drug] to be a successful product in a growing, age-related market."

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