Outlook Therapeutics submits UK Marketing Authorisation Application for wet AMD treatment

In the NORSE ONE, NORSE TWO and NORSE THREE trials, bevacizumab gamma demonstrated a strong safety profile. Image credit: ©Sergey Ryzhov – stock.adobe.com

On Monday, US-based biopharmaceutical company Outlook Therapeutics announced the submission of its Marketing Authorisation Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in a press release.¹ Outlook Therapeutics seeks the MAA for bevacizumab gamma (ONS-5010/LYTENAVA), its investigational formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).

Notably, Outlook Therapeutics completed the submission under the new International Recognition Procedure (IRP). The IRP replaces the previous method of consideration, the EC Decision Reliance Procedure. Under the IRP, the UK MHRA can refer to previous authorisation by a Reference Regulator. In this case, the UK MHRA can rely on a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The EMA issued a positive CHMP opinion for bevacizumab gamma in March 2024.² According to details shared by the company following the positive CHMP opinion, the European Commission is expected to make a decision about the application for bevacizumab gamma later this month.

Bevacizumab-vikg, referred to as bevacizumab gamma in the EU and UK, is intended for intravitreal injection as a treatment for wet AMD and other retinal diseases. It is a recombinant humanized monoclonal antibody, anti-vascular endothelial growth factor (VEGF) agent, and works through “a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.”¹ In a clinical programme, the completed registration trials NORSE ONE, NORSE TWO and NORSE THREE, bevacizumab gamma demonstrated a strong benefit-to-risk safety profile.

Russell Trenary, President and CEO of Outlook Therapeutics, spoke to the company’s excitement at the MAA submission in a press release. He said, “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. On the heels of the recent positive opinion by the CHMP in the EU, we continue to make noteworthy progress toward the potential authorisation of ONS-5010/LYTENAVA in the UK.”

References

1. Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD. Press release. Outlook Therapeutics, Inc. Published 13 May 2024.

2. Hayes H. Outlook Therapeutics receives positive CHMP opinion for bevacizumab for wet age-related macular degeneration. Ophthalmology Times Europe. 22 March, 2024. Accessed 13 May, 2024. https://europe.ophthalmologytimes.com/view/outlook-therapeutics-receives-positive-chmp-opinion-for-bevacizumab-for-wet-age-related-macular-degeneration