FDA Accepts Resubmitted BLA For ONS-5010/LYTENAVA For Wet AMD With PDUFA Date Set For July 29, 2026 – Outlook Therapeutics
Outlook Therapeutics announced the FDA has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.
“We are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval. This is great news for Outlook and the LYTENAVA team, patients and the retina community. We look forward to collaborating with the FDA over the coming weeks. We are incredibly grateful to our teams, partners, and KOLs for their resilience and dedication.” – Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
When approved, ONS-5010/LYTENAVA will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. Outlook Therapeutics has initiated pre-launch activities in anticipation of the pending BLA approval.
