Alcon submits Retaane data; drug on fast track with FDA

Anecortave acetate has been granted fast-track status by the Food and Drug Administration as a therapy for age-related macular degeneration, according to developer Alcon. The FDA’s decision on the drug should come by the second quarter of the year.

Retaane (anecortave acetate for depot suspension, Alcon) has been assessed in clinical trials for “preserving the vision of patients with all forms of wet age-related macular degeneration,” the company said.

According to Alcon, the company submitted to the FDA the results of a clinical pharmacokinetic study evaluating the effectiveness of a counter pressure device in eliminating or minimizing reflux during the administration of Retaane by posterior juxtascleral depot. Data from that trial showed that for all patients treated within a 6-month treatment window who experienced no reflux during their second administration, 57% treated with Retaane maintained vision, compared with 47% treated with photodynamic therapy.

In the pharmacokinetic study, the counter pressure device was effective in controlling drug reflux in 100% of the study participants, Alcon said in a press release. The study also measured the concentration of the drug in blood plasma to confirm that effectively controlling reflux correlated with a higher level of drug absorption.