Alcon Receives FDA Decision on Retaane

Retaane is an injectable steroid suspension that inhibits blood vessel growth. It is a potential treatment of wet age-related macular degeneration. The FDA letter advised Alcon that approval of the drug will require an additional clinical study. The company has no immediate plans to conduct a new study of Retaane (anecortave acetate depot suspension) because of the availability of other similar treatments, such as Macugen and Lucentis. Therefore, Retaane is not expected to become commercially available within the United States. Retaane is available in several countries outside the U.S. Alcon will continue the Anecortave Acetate Risk-Reduction Trial, which has studied the ability of Retaane suspension to reduce the risk of progression from dry to wet age-related macular degeneration. The trial, which has enrolled more than 2,500 patients, could be complete within three years, the company said.