Early FDA approval of LYTENAVA for wet AMD triggers OTLK surge
Early FDA approval of LYTENAVA for wet AMD triggers 24% OTLK surge
- FDA approved ONS-5010/LYTENAVA (bevacizumab-vikg) on July 24, 2026, ahead of July 29 PDUFA date
- First on-label ophthalmic bevacizumab in US, ending reliance on off-label compounded Avastin
- Approval supported by positive NORSE TWO and NORSE EIGHT clinical trial data
- Stock halted on news amid high volatility and retail/investor excitement
- Follows prior CRLs, June 2026 BLA resubmission, and FDA acceptance
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