Age-related macular degeneration

Neovascular age-related macular degeneration (also known as “wet’ AMD) is the leading cause of legal blindness and vision impairment in Americans aged 40 and over. There are an estimated 200,000 new cases annually in the United States and about 500,000 new cases annually worldwide. In 2004, it was estimated that about 3.3 million Americans aged 40 and over were experiencing vision loss or blindness due to AMD. This number is projected to reach 5.5 million by the year 2020. Neovascular AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, the light-sensitive tissue at the back of the eye. Current therapies for AMD have to be injected into the eye every 2-4 weeks for the rest of the life of the patient.

ATG-3 is an antagonist of the nACh receptor pathway in the vasculature and is being studied in the clinic as an anti-angiogenic therapy for neovascular AMD. ATG-3 inhibits endogenous as well as VEGF induced angiogenesis in human retinal endothelial cells. Following topical administration as ATG-3 eye drops, the compound has excellent penetration to the back-of the eye in multiple animal species with no systemic side effects, consistent with the very low levels of the compound found in the blood following eye drop application. Topical administration of ATG-3 also inhibits angiogenic process in animal models of AMD. CoMentis successfully completed a Phase I study in healthy volunteers in the fourth quarter of 2006. Our ongoing 330 patients Phase II dose-ranging study (OPTIMA) is designed to assess safety and efficacy in patients with neovascular or wet AMD. Data from this study is expected in 2009.