MacugenTreatment for Macular Degeneration
Eyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection)
The First Investigational Anti-VEGF Therapy for Neovascular Age-Related Macular Degeneration Granted Priority Review
NEW YORK, August 17, 2004 -- Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET) and Pfizer Inc. (NYSE:PFE) today announced that their complete New Drug Application (NDA) for Macugen (pegaptanib sodium injection) has been accepted by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA satisfied a milestone provision in our collaboration agreement for a further license fee payment from Pfizer to Eyetech of $10 million. Eyetech and Pfizer are partnering to develop and market Macugen, a treatment for neovascular age-related macular degeneration, the leading cause of severe vision loss in patients older than 50 years of age in the developed world.
As part of the Macugen NDA filing, Eyetech and Pfizer requested and have now been granted Priority Review designation from the FDA. Based on the Priority Review designation, the FDA has six months from the submission date, to take action on the NDA filing. The companies submitted the final portion of the NDA, the chemistry, manufacturing and controls (CMC) component, on June 17, under the FDA's Fast Track designation. The FDA and its Dermatologic and Ophthalmic Drugs Advisory Committee will review Macugen on August 27, 2004.
Macugen is a pegylated anti-VEGF aptamer, which binds to and thus inhibits the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular AMD.
About Eyetech Pharmaceuticals, Inc.
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. Eyetech's initial focus is on diseases affecting the back of the eye. The company's most advanced product candidate is Macugen (pegaptanib sodium injection), which Eyetech is developing with Pfizer Inc for the prevention and treatment of diseases of the eye and related conditions. Eyetech's lead clinical trials include two phase 2/3 pivotal clinical trials for the use of Macugen in the treatment of neovascular age-related macular degeneration, a phase 2 clinical trial for the use of Macugen for the treatment of diabetic macular edema and a phase 2 clinical trial for the use of Macugen in the treatment of retinal vein occlusion.
Posted: August 2004
- Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration - December 17, 2004
- FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD - August 27, 2004
- Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration - June 17, 2004
- FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection) - May 26, 2004