Outlook Therapeutics, Inc.
LYTENAVA
neovascular age-related macular degeneration
Resolved
189days ago
FDA decision · Dec 30, 2025
What's at stake
An FDA complete response letter on LYTENAVA for neovascular age-related macular degeneration is in focus around Dec 30, 2025.
Primary source
· SEC 8-K
verified 14h ago
“The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of nAMD, and directed the Division of Ophthalmology and the Office of Specialty Medicine to work with the Company to reach an ”