Outlook Therapeutics Receives FDA Complete Response Letter for ONS-5010/LYTENAVA in Wet AMD Treatment

Outlook Therapeutics has received a Complete Response Letter (CRL) from the US FDA for its biologics license application (BLA) for ONS-5010/LYTENAVA, a treatment for wet age-related macular degeneration (AMD). The FDA has identified only one deficiency, a lack of substantial evidence of effectiveness, and requires confirmatory evidence to support approval. The company plans to work with the FDA to address the issues and will continue its efforts to expand into additional markets in Europe.