October 17, 2005.
Eyetech Pharmaceuticals, Inc. announced today enrollment of the first patient in a Phase 3 randomized, controlled, double-masked, multi-center, comparative dose-finding trial that will compare the safety and efficacy of Macugen(R) (pegaptanib sodium injection) in patients with diabetic macular edema (DME). Diabetic retinopathy score is a pre-specified secondary endpoint of the Phase 3 study. Patients in the Phase 3 study will receive intravitreous injections of 0.3, 0.03, or 0.003 mg of Macugen, or sham injections, every 6 weeks for 3 years. Total planned enrollment for the trial is 900 patients. Enrollment is anticipated to be complete by February 2007. Macugen is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is not approved for the treatment of DME or diabetic retinopathy.
This Phase 3 study follows the prospective analysis of the Phase 2 Macugen DME study, now published in the October 2005 issue of Ophthalmology. DME is a complication of diabetic retinopathy, in which damaged blood vessels in the retina leak fluid into the macula, the part of the retina that provides sharp, central vision, causing it to swell. A retrospective subgroup analysis of this study, which suggests that Macugen may have potential in treating patients with retinal neovascularization associated with diabetic retinopathy, is being presented on October 18th at the American Academy of Ophthalmology (AAO) meeting in Chicago, Illinois.
"With millions of diabetics at risk of losing their vision, there is a significant medical need to find more safe and effective ways to treat diabetic retinopathy and DME," said Michael Altaweel, M.D., Department of Ophthalmology and Visual Sciences, University of Wisconsin. "In limited Phase 2 studies, Macugen, the only anti-VEGF therapy being studied in DME and diabetic retinopathy in large clinical trials, has shown potential in treating these conditions."
Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). Macugen is indicated in the United States and Brazil for the treatment of neovascular age-related macular degeneration (neovascular AMD) and in Canada for the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration. In September 2005, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), issued a positive opinion recommending approval of Macugen for the treatment of neovascular AMD in Europe. Macugen applications have also been filed in twelve additional countries. Eyetech and Pfizer Inc co-promote Macugen in the United States. Eyetech granted Pfizer the exclusive rights to commercialize Macugen in countries outside the United States pursuant to a royalty-bearing licensing agreement.
Diabetic retinopathy is the leading cause of vision impairment and blindness in people 20-74 years of age. An estimated 18 million people diagnosed with diabetes are at risk of vision impairment and vision loss due to diabetes complications. Diabetic retinopathy affects 5.3 million adults in the United States and as many as 24,000 people go blind from the condition each year. Nearly sixty percent of diabetes patients are expected to develop diabetic retinopathy within ten years of their diagnosis, and eighty percent of patients within 15 years of their diabetes diagnosis. Additionally, approximately 75,000 new cases of DME are recorded each year in the United States. There currently is no approved drug treatment for diabetic retinopathy or DME. Currently the only available treatment to minimize vision loss in patients with these conditions is periodic laser surgery, which is not a cure, usually does not restore vision that has already been lost, and may be associated with side effects, such as diminished peripheral and night vision.
About Diabetic Retinopathy and Diabetic Macular Edema
Diabetic retinopathy is a disease affecting the blood vessels of the retina, resulting in multiple abnormalities including impeded blood flow (retinal ischemia) and excessive leakage of fluid from blood vessels that can cause retinal thickening or edema and hemorrhages. When the blood vessel leakage causes swelling within the macula, it is referred to as diabetic macular edema (DME). Patients may also present abnormal blood vessel growth (proliferative diabetic retinopathy) that can lead to profuse hemorrhages and severe retinal damage.
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