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OTLK FDA decision — Jul 24, 2026

✓ APPROVED

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
IndicationNeovascular (wet) age-related macular degeneration (nAMD)
CompanyOutlook Therapeutics, Inc.
Review pathResubmitted BLA, Class 1 review (post-CRL appeal)
Market-cap tierMicro
Cohort decision-day move (history)±7% median

Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.

Primary source: Outlook Therapeutics — "LYTENAVA FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD" (Jul 24 2026).