Outlook Therapeutics submits UK MAA for ONS-5010 (bevacizumab gamma) for wet AMD

Outlook Therapeutics, Inc.

Submitted MAA to UK MHRA via International Recognition Procedure, relying on March 2024 positive CHMP opinion.
ONS-5010 is proposed as the first on-label ophthalmic bevacizumab for wet AMD in the UK.
Clinical program support from three completed registration trials: NORSE ONE, TWO, and THREE.
EU decision on CHMP opinion expected within ~67 days; applies to 27 Member States plus Iceland, Norway, Liechtenstein.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.