Kodiak Sciences drugs meet primary endpoints in wet AMD trial

Kodiak Sciences Inc. (NASDAQ: KOD) announced that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted met primary endpoints in the Phase 3 DAYBREAK study in patients with wet age-related macular degeneration (wAMD), according to a company press release dated Sept. 28, 2026.

Zenkuda met its primary endpoint with a p-value of 0.0007, demonstrating non-inferiority in vision gains compared to aflibercept at year one. In the trial, 54% of patients achieved a six-month dosing interval using strict treat-to-dryness retreatment criteria. Zenkuda showed a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate, compared with 0.9% for aflibercept.

Tabirafusp-ted met its vision primary endpoint with a p-value of 0.0036 and its anatomical key secondary endpoint with a p-value of less than 0.0001. The drug showed a 0.4% intraocular inflammation rate and a 0% cataract adverse event rate.

Kodiak plans to submit a biologics license application (BLA) for Zenkuda in the fourth quarter of 2026, covering three indications: wAMD, diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The submission would draw on data from five Phase 3 studies: DAYBREAK and DAYLIGHT in wAMD, GLOW1 and GLOW2 in DR, and BEACON in RVO.

Tabirafusp-ted is currently enrolling patients in the Phase 3 ALTO study, which is evaluating the drug against aflibercept in diabetic macular edema. Post-hoc analyses are planned to identify wAMD patient subgroups that may benefit from IL-6 inhibition.

Kodiak also stated it expects topline data from the Phase 3 PEAK study of KSI-101 in macular edema secondary to inflammation in December 2026, with a planned BLA submission for that asset in the second quarter of 2027.

Neither Zenkuda nor tabirafusp-ted has received regulatory approval. All BLA submissions and approval timelines remain subject to regulatory review.

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