The eye care company Alcon, Inc. has announced that the company received an approvable letter from the US Food and Drug Administration (FDA) for Retaane 15 mg (anecortave acetate depot suspension) for the treatment of wet age-related macular degeneration (AMD).
The letter advised Alcon that approval would require an additional clinical study. The company has no immediate plans to conduct a new study of Retaane suspension for the treatment of wet AMD, due to the difficulty of recruiting patients for such a study in light of other treatments currently available, the company announced in a press release.
The company believes that Retaane 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 Retaane suspension to reduce the risk for the progression of the dry form to the wet form of AMD. This trial, which is fully enrolled with more than 2,500 patients, is expected to be completed within three years, said the company press release.
Alcon continues to actively pursue other retinal pharmaceutical research programs in its pipeline that it believes have the potential to lead to effective treatments for wet AMD. In addition, the company is conducting clinical studies of anecortave acetate, the active ingredient in Retaane, for the treatment of glaucoma.
Alcon, Inc. is the world's leading eye care company, with sales of approximately $4.9 billion in 2006. Alcon, which has been dedicated to the ophthalmic industry for 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye.