Wet age-related macular degeneration (AMD)
OTLKOutlook TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Approved update for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) in Wet age-related macular degeneration (AMD) . The expected timing is based on the latest available company guidance and may change.
05/15/26:- Dispute meeting completed; FDA decision expected May 2026; Europe Q2 unit sales down 10%. 05/26/26:- FDA granted appeal; expects BLA resubmission June 2026. Class 1; decision expected within 60 days. 06/01/26:- BLA resubmitted; Class 1 review. PDUFA decision expected within 60 days (Late July 2026 est.). 06/16/26:- FDA set PDUFA action date July 29, 2026 for Class 1 resubmitted BLA. 07/24/26:- FDA approved LYTENAVA for wet AMD. Plans U.S. availability before year-end.
Verification
Confirm timing and program details against the company announcement or filing.