Alcon files NDA for wet AMD drug

Fort Worth, TX-The FDA has accepted the new drug application (NDA) for Alcon Inc.'s anecortave acetate for depot suspension (RETAANE) for controlling angiogenesis in wet age-related macular degeneration.

The product, which has been given fast-track status by the FDA, could be approved by late May, according to an Alcon spokeswoman.

Alcon also has submitted to the FDA results of a clinical pharmacokinetic study evaluating the effectiveness of a counter- pressure device used to eliminate or minimize reflux during the administration of the drug. The results showed that the counter-pressure device controlled reflux in 100% of study participants.

The study also found that, by controlling reflux, a higher level of the drug was absorbed than when the counter-pressure device was not used. Results of the study were also presented during the 28th annual Macula Society Meeting in Key Biscayne, FL.