Alcon's Retaane gets FDA approvable letter

Swiss eye care specialist Alcon has received an approvable letter from the US Food and Drug Administration regarding its wet age-related macular degeneration drug Retaane (anecortave acetate depot suspension). The agency said that an additional clinical trial would be required prior to regulatory approval.

In response, Alcon said that it has no immediate plans to carry out a further Retaane study. It cited both the difficulty in recruiting patients and the relatively large number of alternative wet AMD treatments that are available, including Novartis' Lucentis (ranibizumab) and Pfizer's Macugen (pegaptanib sodium injection; Marketletters passim), as reasons for its current position.

Despite this, Alcon said that it continues to believe that Retaane "could play a role in the treatment of wet AMD," and would continue to support the Anecortave Acetate Risk-Reduction Trial (AART), which is examining the drug's effect on delaying progression from the dry to the wet form of the disease. The firm added that it is conducting trials of anecortave acetate in glaucoma indications.