Outlook Therapeutics Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD

• UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA (bevacizumab gamma)
  

ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and Europe, today announced the submission of its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD).

The submission was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency’s CHMP concerning an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized by a Reference Regulator (RR). In this case this is the EMA.

“The submission of our MAA to the MHRA is another step closer to the possibility of offering clinicians and their patients in the UK market the only on-label, ophthalmic bevacizumab to treat wet AMD,” said Russell Trenary, President and CEO of Outlook Therapeutics. “On the heels of the recent positive opinion by the CHMP in the EU, we continue to make noteworthy progress toward the potential authorization of ONS-5010/LYTENAVA in the UK.”

The MAA submission is supported by results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE.

As previously announced, Outlook Therapeutics received a CHMP positive opinion on March 22, 2024 concerning an application for grant of marketing authorization for ONS-5010/LYTENAVA in the EU. The European Commission is expected to make a decision within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein.