FDA requests more research for AMD drug

October 15, 2007

Alcon Inc. says it has no immediate plans to conduct the additional clinical study of anecortave acetate depot suspension 15 mg (Retaane) required by the FDA in an approval letter the agency recently sent to the company.

Huenenberg, Switzlerland-Alcon Inc. says it has no immediate plans to conduct the additional clinical study of anecortave acetate depot suspension 15 mg (Retaane) required by the FDA in an approval letter the agency recently sent to the company. Recruiting patients for such a study would be difficult in light of other treatments currently available in the United States, the company said in a statement.

The therapy, designed to treat exudative neovascular (wet) age-related macular degeneration (AMD), is commercially available in several countries outside the United States.

"The company continues to believe that [anecortave acetate] suspension could play a role in the treatment of wet AMD. As a result, Alcon will continue to support the Anecortave Acetate Risk-Reduction Trial (AART) that is studying the ability of [anecortave acetate] suspension to reduce the risk for the progression of the dry form to the wet form of AMD," according to the statement. Enrollment in AART is complete, with more than 2,500 patients. The trial is expected to be finished within 3 years, the company said.