Outlook Therapeutics Submits UK Marketing Authorisation Application for Wet AMD Drug

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. The MAA is for bevacizumab gamma (ONS-5010/LYTENAVA), its investigational formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).

New Procedure Facilitates MAA Submission

The submission was completed under the new International Recognition Procedure (IRP), replacing the previous EC Decision Reliance Procedure. Under the IRP, the UK MHRA can refer to previous authorizations by a Reference Regulator, such as the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued in March 2024. Following the positive CHMP opinion, the European Commission is expected to make a decision about the application for bevacizumab gamma later this month.

Bevacizumab Gamma: A Potential Treatment for Wet AMD

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

Outlook Therapeutics' CEO Expresses Optimism

Russell Trenary, President and CEO of Outlook Therapeutics, expressed excitement at the MAA submission, stating, “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 authorization of ONS-5010/LYTENAVA in the UK.”

About Wet AMD
Wet age-related macular degeneration (AMD) is a progressive eye condition characterized by the abnormal growth of blood vessels beneath the macula, the central part of the retina. These blood vessels leak fluid and blood into the retina, leading to distorted or blurred vision, and if left untreated, can result in permanent vision loss. Wet AMD typically affects individuals over the age of 50 and is a leading cause of severe vision impairment in older adults. Unlike dry AMD, which progresses slowly, wet AMD can cause rapid and significant vision changes, making early detection and treatment crucial for preserving vision.