A corporate account gives you access to licensed reports and subscriptions, the latest news, a personalized dashboard, and weekly emails with news and data.
Outlook Therapeutics announced May 13 that it had submitted a marketing authorization application to the UK’s Medicines and Healthcare Products Regulatory Agency for ONS-5010 (bevacizumab gamma) for wet age-related macular degeneration.
The submission was completed under the new International Recognition Procedure, which allows UK regulators to rely on a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in weighing a UK marketing application. ONS-5010 earned a positive CHMP opinion in March 2024 and is awaiting a decision on EU approval.
The US FDA declined to approve ONS-5010 in August 2023, citing several chemistry, manufacturing, and controls issues and observations from pre-approval manufacturing inspections, plus a need for further confirmatory clinical evidence.
The NORSE EIGHT Phase III trial began dosing in January 2024. Outlook, of Iselin, New Jersey, said it expects to resubmit its biologics license application (BLA) in the US for ONS-5010 by the end of 2024.
With ONS-5010, Outlook aims to replace the off-label practice of using intravenous bevacizumab (the cancer drug Avastin) repackaged for intravitreal injection.