Outlook Therapeutics requests Type A FDA meeting after CRL for wet AMD drug ONS-5010

Outlook Therapeutics, Inc.

CRL dated Dec 30, 2025 cited lack of substantial evidence; company believes it contradicts alignment from Sept 2025 meeting.
Phase 3 NORSE TWO met primary endpoint (15-letter gain at 12 months); NORSE EIGHT missed primary at 8 weeks.
ONS-5010/LYTENAVA is already approved and commercially available in EU and UK for wet AMD.
FDA has not raised safety concerns; company plans to pursue resolution via Type A meeting.

item 8.01 item 9.01

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