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www.fdanews.com/articles/81752-eyetech-announces-enrollment-of-the-first-patient-in-a-clinical-trial-of-macugen

EYETECH ANNOUNCES ENROLLMENT OF THE FIRST PATIENT IN A CLINICAL TRIAL OF MACUGEN

October 18, 2005

Eyetech Pharmaceuticals has enrolled the first patient in a Phase III randomized, controlled, double-masked, multicenter, comparative dose-finding trial that will compare the safety and efficacy of Macugen (pegaptanib sodium injection) in patients with diabetic macular edema (DME). Diabetic retinopathy score is a pre-specified secondary endpoint of the study.

Patients in the study will receive intravitreous injections of 0.3 mg, 0.03 mg, or 0.003 mg of Macugen every six weeks for three years. Total planned enrollment for the trial is 900 patients. Enrollment is anticipated to be complete by February 2007. Macugen is indicated for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is not approved for the treatment of DME or diabetic retinopathy.