Outlook Therapeutics Wins FDA Appeal, Plans June 2026 Resubmission for Lytenava

Published on May 27, 2026
ISELIN, N.J.—Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company, announced that the Food and Drug Administration’s (FDA) office of new drugs has granted its appeal in the formal dispute resolution (FDR) process for ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD). The FDA concluded that substantial evidence of effectiveness has been established for Lytenava for the treatment of nAMD. As a result, Outlook Therapeutics said it expects to resubmit the ONS-5010/Lytenava (bevacizumab-vikg) biologics license application (BLA) in June 2026.
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