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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.
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.
