USFDAJun 16, 2026, 08:03 AM
Outlook Therapeutics FDA Accepts BLA Resubmission; PDUFA July 29, 2026
AI Summary
Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD). The resubmission has been designated as a Class 1 review, with a PDUFA target action date of July 29, 2026. If approved, ONS-5010/LYTENAVA™ would be the first and only FDA-approved ophthalmic formulation of bevacizumab, and the company has already initiated pre-launch activities.
Key Highlights
- FDA acknowledged receipt of the Biologics License Application (BLA) resubmission for ONS-5010/LYTENAVA™ for nAMD.
- The resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.
- ONS-5010/LYTENAVA™ aims to be the first and only FDA-approved ophthalmic formulation of bevacizumab.
- Outlook Therapeutics has initiated pre-launch activities in anticipation of potential BLA approval.
- LYTENAVA™ (bevacizumab gamma) has received Marketing Authorization in the European Union and the UK.
- Commercial launch of LYTENAVA™ has commenced in Germany, Austria, and the UK.
Price Impact
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