Othera Pharmaceuticals and the National Eye Institute Collaborate in Dry AMD Study; A Phase II Study of OT-551 Antioxidant Eye Drop in Participants with Bilateral Geographic Atrophy Associated with Age-Related Macular Degeneration.

EXTON, Pa. -- Othera Pharmaceuticals, Inc. today announced the initiation of a Phase II clinical trial by the National Eye Institute (NEI) of Othera's topical eye drop OT-551 in patients with Geographic Atrophy (GA), a sign of dry or atrophic Age-Related Macular Degeneration (AMD). The NEI will investigate OT-551's potential to slow enlargement of the atrophic area in the macula and prevent progression to the vision-threatening advanced stages of AMD.

AMD is the leading cause of blindness in the U.S. in persons over age 55. As many as seven million Americans have early- to intermediate-stage AMD, of whom approximately one million have Geographic Atrophy (GA). Persons with GA in both eyes are at high risk of progression to advanced AMD and potential blindness. The only current therapy for dry AMD is high-dose oral vitamin and zinc supplements, which the NEI showed to be modestly effective in slowing progression of intermediate to advanced AMD.

This Phase II study will enroll ten patients with bilateral Geographic Atrophy (GA). Patients will receive three daily doses of OT-551 eye drop over two years. The primary efficacy measure will be percent change in area of GA in each eye, as measured by fundus photo grading. Secondary measures will include: progression to advanced neovascular or wet AMD, progression of GA area based on autofluorescence, changes in contrast sensitivity, drusen area, and best-corrected visual acuity, and number of eyes developing advanced AMD. Additional outcomes will also be measured regarding lens opacity as part of an on-going collaboration between Othera and the NEI on preventing or slowing the progression of cataract formation.

OT-551 is a low molecular weight compound that has shown benefit in various animal models of macular degeneration, exhibiting both anti-inflammatory and anti-angiogenic effects. It has high bioavailability in the eye and distributes to the retina after topical dosing. OT-551 is also currently being tested in Othera's Phase II trial for preventing or slowing the progression of post-vitrectomy nuclear cataract. Further Phase II studies are planned with OT-551 for AMD and other indications.

Othera Pharmaceuticals, Inc. is a privately-held, ophthalmic pharmaceutical company located in Exton, PA. Othera is developing proprietary drugs to treat or prevent the three leading causes of blindness and vision impairment worldwide - AMD, cataract, and glaucoma. More information on OT-551 is available on the company's website at: www.othera.com.