FDA Accepts BLA Resubmission for Wet AMD Drug, Sets July 29 PDUFA Date

Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an ophthalmic formulation for treating wet age-related macular degeneration (wet AMD). The FDA classified the BLA as a Class 1 review, indicating a 60-day review period.

Key Details

• Product: ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational treatment for wet AMD.
• Regulatory Milestone: The FDA has accepted the BLA resubmission and classified it as a Class 1 review.
• PDUFA Goal Date: The FDA has set a target action date of July 29, 2026.