Outlook Resubmits BLA to US FDA for Ophthalmic Bevacizumab (Lytenava)

Outlook Therapeutics reported Feb. 28 that it had resubmitted its biologics license application (BLA) to the US FDA for ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD).

With Lytenava, Outlook, of Iselin, New Jersey, aims to replace the off-label practice of using intravenous bevacizumab (the cancer drug Avastin) repackaged for intravitreal injection.

The FDA rejected Lytenava’s application 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 trial was launched in January 2024 to address those concerns. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, Outlook said. 

Lytenava (bevacizumab-vikg) was approved for wet AMD in the EU in May 2024 and in the UK in July 2024. The company, with its commercial partner, Cencora, said it is readying a launch in Europe in H1-2025.