Outlook Therapeutics announces FDA acceptance of resubmitted biologics license application for ONS-5010/Lytenava (bevacizumab-vikg) as a treatment for wet AMD

Outlook Therapeutics

16 June 2026 - Outlook Therapeutics today announced the US FDA has acknowledged receipt of the resubmission of the biologics license application for ONS-5010/Lytenava for the treatment of neovascular age-related macular degeneration, or wet AMD. 

The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of 29 July 2026.

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Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration