Kodiak's Zenkuda and tabirafusp-ted hit primary endpoints in Phase 3 DAYBREAK trial

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 in patients with wet age-related macular degeneration.¹

Zenkuda met the primary endpoint with a p-value of 0.0007, demonstrating meaningful vision gains as well as rapid and sustained retinal drying with the majority of patients (54%) on 6-month dosing.¹ The DAYBREAK study showed that both Zenkuda and tabirafusp-ted achieved non-inferiority in vision gains compared to aflibercept at year one.¹

Zenkuda demonstrated a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate, versus 0.9% for the aflibercept comparator.¹ Tabirafusp-ted showed a 0.4% intraocular inflammation rate and a 0% cataract adverse event rate, compared with 0.9% for aflibercept.¹

For tabirafusp-ted, the drug met the vision primary endpoint with a p-value of 0.0036 and the anatomical key secondary endpoint with a p-value of less than 0.0001.¹

Kodiak plans to submit Zenkuda data to regulatory authorities in the fourth quarter of 2026, drawing on five positive Phase 3 studies: DAYBREAK and DAYLIGHT in wAMD, GLOW and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion.¹

In the GLOW and GLOW2 studies, Zenkuda treated diabetic retinopathy patients and prevented disease progression, with 100% of patients on extended 6-month dosing at Year 1.¹

Kodiak has also advanced tabirafusp-ted into the registrational Phase 3 ALTO study to explore superiority over aflibercept in diabetic macular edema, which is currently enrolling patients.¹ The company's third late-stage asset, KSI-101, is being developed for macular edema secondary to inflammation, with a first topline readout expected in December 2026.¹