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.