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Othera Pharmaceuticals Initiates Phase 2 Clinical Trial for OT-551 in Cataract Prevention; Trial to Address Rapidly-Progressing Form of Cataracts Resulting from Retinal Surgery.

EXTON, Pa. -- Othera Pharmaceuticals, Inc., a specialty pharmaceuticals company focused on treating eye disease, today announced that it has initiated a Phase 2 clinical trial of its lead compound, a topically administered eye drop, OT-551.

The twelve-month, double-masked, randomized, placebo-controlled study is designed to evaluate the ability of OT-551 to prevent or arrest the progression of cataracts in patients who have undergone vitrectomy surgery, a procedure to correct retinal defects. OT-551, which has been shown to be a potent catalytic antioxidant, recently completed a Phase 1 safety and comfort study in healthy volunteers.

"It is generally accepted in the ophthalmology community that a link exists between vitrectomy surgery and subsequent cataract formation," said Dr. Leonard Parver, Othera's Medical Director and a practicing retinal surgeon. "Removal of the vitreous from the back of the eye exposes the lens to oxygen free radicals, and in the great majority of the cases where the patients have their natural lenses, vision-impairing opacities will form within 9-12 months. Moreover, the cataract that forms is most often a nuclear cataract, the most common type, which is the same as the age-related cataract that occurs in a large percentage of the elderly population."

Preclinical research results indicate additional uses for OT-551, including treatment of early stage and advanced dry age-related macular degeneration (AMD) by protecting against retina photoreceptor cell death and inhibiting angiogenesis, the growth of small blood vessels leading to the wet-form of AMD. A leading cause of vision loss, AMD affects approximately 10 million Americans.

"OT-551 is a novel small molecule that is topically dosed in an eye drop and has the unique ability to penetrate cell membranes and reach both the front and the back of the eye," said David S. Joseph, chairman and CEO of Othera Pharmaceuticals. "In addition to cataract treatment, we are very encouraged by research results demonstrating that OT-551 may be able to treat AMD, as well as dry eye syndrome. We expect to begin Phase 2 trials for these indications next year."

About Vitrectomy Surgery and Post-Vitrectomy Cataracts

Approximately 200,000 vitrectomies are performed by retinal surgeons in the U.S. each year for retinal repair. The procedure typically involves removal of the vitreous, the gel-like substance that acts as a barrier and fills the back of the eye. In removing the vitreous, the patient's lens is suddenly exposed to oxygen from the blood vessels in the retina. Oxygen free radicals are produced as a result and these then damage proteins in the nucleus of the lens. These damaged proteins aggregate, resulting in opacification of the lens and formation of vision-impairing cataracts. The post-vitrectomy cataract that forms as a result of oxidative damage is a nuclear cataract, the same as the more common age-related cataract, which affects as many as 35 million Americans.

About Othera Pharmaceuticals

Founded in 2002, Othera Pharmaceuticals, Inc. is a specialty pharmaceuticals company focused on developing treatments for major age-related eye diseases. In addition to its lead compound, OT-551, Othera is also developing OT-730 as a novel improved beta-blocker for treatment of glaucoma. OT-730 is designed to have excellent beta-blocking activity in the eye, yet easily break down into inert components upon entry into the bloodstream. Today's marketed beta-blockers as a class are the most widely-prescribed drugs by volume for glaucoma, but suffer from the potential danger of systemic side effects. Initial preclinical studies support the concept that OT-730 could overcome the systemic side effect problem, and Phase 1 and Phase 2 clinical trials to demonstrate safety and efficacy are planned to begin in 2006. For information please visit Othera's website at
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 7, 2005
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