Biopharmaceutical company Outlook Therapeutics has won an appeal with the U.S. Food and Drug Administration (FDA) for its investigational eye drug Lytenava (ONS-5010/bevacizumab-vikg), after the product had been repeatedly rejected for use in wet age‑related macular degeneration (nAMD). The FDA’s Office of New Drugs concluded that Outlook established "substantial evidence of effectiveness" for Lytenava, based on the NORSE TWO trial plus confirmatory data including NORSE EIGHT, natural‑history information, and mechanistic and pharmacodynamic data. As a result, Outlook plans to resubmit its Biologics License Application (BLA) in June 2026; that resubmission is expected to be a Class 1 filing, with the FDA decision anticipated within 60 days of receipt, offering a fast‑tracked path toward potential U.S. approval. Sources: Outlook Therapeutics Wins FDA Appeal for Lytenava, Plans BLA ... Valeant wins approval of eye drug that FDA rejected twice over manufacturing problem...
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