Outlook Therapeutics, Inc.
ONS-5010/LYTENAVA™ (bevacizumab-vikg)
retinal diseases
Resolved
189days ago
FDA decision · Dec 30, 2025
What's at stake
An FDA complete response letter on ONS-5010/LYTENAVA™ (bevacizumab-vikg) for retinal diseases is in focus around Dec 30, 2025.
Primary source
· SEC 8-K
verified 15h ago
“The Company engaged in the FDR process after its recent Type A meeting with the Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) related to the December 30, 2025 Complete Response Letter (CRL) for the BLA for ONS-”