Outlook Therapeutics resubmits biologics license application for ONS-5010

Outlook Therapeutics

3 November 2025 - Outlook Therapeutics today announced it has resubmitted its biologics license application to the US FDA for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. 

ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration.

Read Outlook Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration