Othera Pharmaceuticals, Inc.,
Othera Pharmaceuticals, Inc., today 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, timololand
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 wellaccepted
class of marketed drugs. OT-730 is a novel, internally developed next generation topical betablocker
designed to lower intra-ocular pressure (IOP), the leading risk factor for developing glaucoma. Betablockers
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 betablockers
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 betablockers
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 diseaseinduced
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.
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