Kodiak Sciences Inc. announced on September 28, 2026, that the primary endpoints were met for both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) in the Phase 3 DAYBREAK study for wet age-related macular degeneration (wAMD).
Zenkuda met its primary endpoint with a p-value of 0.0007. The study demonstrated that Zenkuda achieved non-inferiority in vision gains compared to aflibercept at year one. The company reported that Zenkuda showed strong immediacy of clinical effect, matching or exceeding aflibercept during the loading phase. Additionally, Zenkuda demonstrated durability, with 54% of patients achieving a 6-month dosing interval at year one under strict treat-to-dryness retreatment criteria.
Regarding safety, Zenkuda showed a 0% rate of intraocular inflammation and a 0.5% cataract adverse event rate, compared to 0.9% for the aflibercept comparator.
Tabirafusp-ted also met the vision primary endpoint (p-value of 0.0036) and the anatomical key secondary endpoint (p-value of <0.0001). The safety profile for tabirafusp-ted was reported as favorable, with 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. This submission will include data from five positive Phase 3 studies across wAMD, diabetic retinopathy, and retinal vein occlusion.
