FDA issues Complete Response Letter for Outlook Therapeutics' ONS-5010 BLA for wet AMD

Outlook Therapeutics, Inc.

FDA CRL states additional mechanistic/natural history data does not alter prior conclusion; confirmatory efficacy evidence needed but not defined.
Outlook Therapeutics disagrees with decision and is exploring all available U.S. approval pathways.
ONS-5010 (LYTENAVA) already approved in EU and UK; commercially available in Germany and UK since June 2025.
CEO Bob Jahr reaffirms commitment to bringing first FDA-approved on-label bevacizumab for wet AMD to U.S. patients.
Company continues to expand European presence and seek commercial partners outside Europe.

item 8.01 item 9.01

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