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FDA requires additional clinical study before approval of Alcon AMD treatment
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HUENENBERG, Switzerland — Alcon has received an approvable letter from the U.S. Food and Drug Administration for Retaane, its anecortave acetate treatment for wet age-related macular degeneration. However, the FDA will require an additional clinical trial before it grants final approval, according to an Alcon press release.
Alcon has no immediate plans to conduct a new study due to the difficulty of recruiting patients in light of other treatments currently available for wet AMD, the release said.
However, the company continues to believe that Retaane (15 mg anecortave acetate suspension) could play a role in the treatment of wet AMD. Alcon plans to continue supporting the Anecortave Acetate Risk-Reduction Trial, which is studying the ability of Retaane to reduce the risk of the progression from the dry form of AMD to the wet form. This trial, which is fully enrolled with more than 2,500 patients, is expected to be completed within 3 years, according to the release.
In addition, Alcon is conducting clinical studies of anecortave acetate, the active ingredient in Retaane, for the treatment of glaucoma.
Retaane suspension remains commercially available in several countries outside of the United States.