FDA committee gives AMD drug favorable review; delays formal vote for now

September 10, 2004

The FDA's Dermatologic & Ophthalmic Drugs Advisory Committee met Aug. 27 to begin a priority review of the clinical submission for the investigational drug pegaptanib sodium injection (Macugen) for the treatment of neovascular age-related macular degeneration (AMD).

The FDA's Dermatologic & Ophthalmic Drugs Advisory Committee met Aug. 27 to begin a priority review of the clinical submission for the investigational drug pegaptanib sodium injection (Macugen) for the treatment of neovascular age-related macular degeneration (AMD).

In accordance with the rolling submission process of a priority review, the advisory committee did not take a formal vote immediately. Co-developed by Eyetech Pharmaceuticals Inc. and Pfizer Ophthalmics, pegaptanib sodium received priority review status from the FDA since it is a product that addresses an unmet medical need.

Eyetech and Pfizer submitted the new drug application (NDA) for pegaptanib sodium on June 17. The FDA takes into consideration the deliberations of the advisory committee as part of its review of NDAs.

Eyetech's lead clinical trials include two phase II/III pivotal clinical trials for the use of pegaptanib sodium in the treatment of neovascular AMD; a phase II clinical trial for the use of pegaptanib sodium for the treatment of diabetic macular edema; and a phase II clinical trial for the use of pegaptanib sodium in the treatment of retinal vein occlusion.