Fort Worth, TX?Alcon Inc. has withdrawn its application for European marketing authorization for anecortave acetate suspension for depot injection (Retaane) 30 mg/ml after being told that more clinical data would be necessary for approval.
Fort Worth, TX-Alcon Inc. has withdrawn its application for European marketing authorization for anecortave acetate suspension for depot injection (Retaane) 30 mg/ml after being told that more clinical data would be necessary for approval.
The company said in a prepared statement that the European Medicines Agency and the FDA had informed Alcon that it would need additional clinical data from existing and/or new clinical trials to support approval.
Alcon said it is revising its clinical strategy and plans to continue developing the drug for wet age-related macular degeneration in the United States, Europe, and key markets around the world. No timeframe was announced.
