Outlook Therapeutics FDA accepts FDRR for ONS-5010; meeting set for April 2026

Outlook Therapeutics, Inc.

FDA accepted Formal Dispute Resolution Request for ONS-5010/LYTENAVA (bevacizumab) for wet AMD.
Meeting with deciding official scheduled for April 2026; follows Type A meeting on March 2, 2026.
Company cites NORSE TWO and NORSE EIGHT data supporting efficacy/safety; no safety concerns raised.
If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing.

item 8.01 item 9.01

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