Kodiak Sciences Says Phase 3 DAYBREAK Study Met Primary Endpoints With Zenkuda (Tarcocimab Tedromer) And Tabirafusp-ted (KSI-501) Showing Non-inferiority In Vision Gains For Wet Age-related Macular Degeneration Vs. Aflibercept At Year One
Benzinga·09/28/2026 10:34:12
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- Zenkuda (tarcocimab tedromer) met the primary endpoint (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, establishing a first-line benchmark in wet age-related macular degeneration (wAMD)
- Zenkuda multi-indication biologics license application (BLA) planned for the fourth quarter of 2026 to include five positive Phase 3 studies across wAMD, diabetic retinopathy and retinal vein occlusion
- Tabirafusp alfa tedromer (tabirafusp-ted) met the vision primary endpoint (p-value of 0.0036) and anatomical key secondary endpoint (p-value of <0.0001)
- Post-hoc analyses to identify which treatment naïve wAMD patient sub-groups can benefit from IL-6 inhibition are planned. Tabirafusp-ted development program is accelerating in diabetic macular edema and actively enrolling in the ALTO Phase 3 Study
- Zenkuda and tabirafusp-ted demonstrated safety consistent with the established safety profile of aflibercept