Alcon gets 2nd review of potential AMD treatment

Fort Worth, TX-Alcon Inc. has filed the second of three parts of its "rolling" new drug application for anecortave acetate for depot suspension (Retaane) 15 mg, an investigational treatment for patients with wet age-related macular degeneration (AMD).

The company, which won acceptance into the FDA's Pilot 1 Continuous Marketing Application program because of the drug's potential as a treatment for a significant unmet medical need, said it expects to submit the final portion of the filing in the fourth quarter of this year.

Alcon said it has answered all questions with regard to the second portion, the pre-clinical unit, which was submitted last March. The first portion, called the Chemistry, Manufacturing and Controls unit, was submitted in 2003 and the FDA has finished its initial review. The pre-approval inspection of Alcon's manufacturing facility also was completed without any negative findings, Alcon said.

In other news, the FDA has approved an expanded treatment range for the company's customized wavefront-guided LASIK procedure (CustomCornea). The procedure, performed with the LADARVision System, extends the treatment of myopia up to -8 D (from -7 D) and astigmatism up from -0.5 to -4 D.

The approval gives Alcon the broadest wavefront-guided treatment range of any refractive laser system in the United States, the company said.