Outlook Therapeutics, Inc.
ONS-5010/LYTENAVA
neovascular age-related macular degeneration (nAMD)
Resolved
189days ago
FDA decision · Dec 30, 2025
What's at stake
An FDA complete response letter on ONS-5010/LYTENAVA for neovascular age-related macular degeneration (nAMD) is in focus around Dec 30, 2025.
Primary source
· SEC 8-K
verified 14h ago
“the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™”