LYTENAVA (bevacizumab-vikg), also known as ONS-5010, approved as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of neovascular (wet) age-related macular degeneration (nAMD) (Jul 24 2026). The approval followed a resubmitted BLA (Class 1 review) after a successful appeal of the December 2025 Complete Response Letter; the FDA acted ahead of the July 29 2026 PDUFA target date.
Run-up & decision-day reaction
Gray = run-up into the FDA decision; gold dot & dashed line = the decision day (Jul 24 2026); colored line = the day-of reaction and after. Day-of move: +6% (decision-day close vs prior close). Daily closes via Polygon. Not a prediction.
Key facts
FDA decision date2026-07-24
PDUFA target date2026-07-29 (acted early)
OutcomeApproved
Drug / candidateLYTENAVA (bevacizumab-vikg, ONS-5010)
ClassOphthalmic anti-VEGF (bevacizumab): first FDA-approved ophthalmic bevacizumab
Was LYTENAVA (bevacizumab-vikg, ONS-5010) approved by the FDA?
Yes. The FDA approved the application for LYTENAVA (bevacizumab-vikg, ONS-5010) on July 24, 2026. The primary source is linked on this page.
Which company is behind LYTENAVA (bevacizumab-vikg, ONS-5010)?
LYTENAVA (bevacizumab-vikg, ONS-5010) is a Outlook Therapeutics, Inc. (OTLK) program. The FDA decision came on July 24, 2026; the company's own announcement is linked on this page.
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