Alcon submits final NDA for anecortave acetate

February 15, 2005

Fort Worth, TX—Alcon Laboratories Inc. has submitted the third and final reviewable unit of its new drug application (NDA) for anecortave acetate for depot suspension (Retaane) to the FDA.

Fort Worth, TX-Alcon Laboratories Inc. has submitted the third and final reviewable unit of its new drug application (NDA) for anecortave acetate for depot suspension (Retaane) to the FDA.

Alcon is seeking approval of anecortave acetate for the treatment of subfoveal choroidal neovascularization due to age-related macular degeneration.

The drug is an angiostatic steroid delivered as a juxtascleral injection at a dose of 15 mg.

The FDA is reviewing the anecortave acetate NDA under its new Pilot 1 Continuous Marketing Application (CMA) program for fast track-designated products. That program allows designated NDAs to be submitted in specified reviewable units as each is completed.

Alcon filed the Chemistry, Manufacturing, and Controls unit in 2003 and the Pre-Clinical unit in March 2004, and the FDA has completed its initial review of both of those portions. Formal acceptance by the FDA of the third NDA unit can take up to 45 days.

The FDA has also completed its pre-approval inspection of Alcon's manufacturing facility without any negative findings.