Outlook Therapeutics Announces Completion of Patient Enrollment in NORSE EIGHT Clinical Trial Page 1

• NORSE EIGHT topline results expected in Q4 of calendar year 2024

ISELIN, NJ, Sept. 4, 2024 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that received regulatory approval in the European Union and the United Kingdom earlier this year for the first approved use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment in its NORSE EIGHT clinical trial evaluating ONS-5010 in patients with wet AMD. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA and, if successful, is the last anticipated clinical trial required prior to Outlook Therapeutics' anticipated resubmission of the Biologics License Application (BLA) for ONS-5010.

NORSE EIGHT is a randomized, controlled, parallel, masked non-inferiority study in newly diagnosed subjects with wet AMD randomized 1:1 to receive 1.25 mg of ONS-5010 or 0.5 mg of ranibizumab intravitreal injection. Subjects will receive injections on Day 0 (randomization), Week 4, and Week 8. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline to Week 8. Outlook Therapeutics remains on schedule to report topline results from NORSE EIGHT in the fourth quarter of calendar year 2024. Resubmission of the ONS-5010 BLA is planned for the first quarter of calendar year 2025.