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www.fdanews.com/articles/90234-athenagen-reports-safety-data-on-eyedrop-for-wet-amd

ATHENAGEN REPORTS SAFETY DATA ON EYEDROP FOR WET AMD

February 5, 2007

Athenagen has completed a Phase I clinical study of ATG3, the company's topical eyedrop therapy for neovascular or wet age-related macular degeneration (AMD). ATG3, a proprietary ophthalmic formulation of mecamylamine, is an antagonist of the nicotinic acetylcholine receptor pathway that mediates angiogenesis. Studies in animal models have demonstrated excellent penetration of the proprietary ATG3 formulation into the retina and choroid following eyedrop application.

ATG3 was evaluated in a randomized, double-blind, placebo-controlled Phase I study, which enrolled 80 healthy volunteers in single- and multiple-ascending-dose regimens for up to 14 days of therapy. Subjects received study medication twice daily. The primary endpoint was ocular and systemic safety and included detailed ocular slit lamp examination.

Athenagen's Phase II clinical trial, which is expected to begin this quarter, will be a placebo-controlled, double-blind, randomized, dose-ranging study designed to evaluate both safety and efficacy in patients with wet AMD. The 330-patient study will be conducted at multiple centers worldwide. Athenagen expects to have interim efficacy data by mid-2008.