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

Kodiak Sciences announced that its Phase 3 DAYBREAK study for Zenkuda (tarcocimab tedromer) and Tabirafusp-ted (KSI-501) met primary endpoints, showing non-inferiority in vision gains for wet age-related macular degeneration compared to aflibercept. Zenkuda achieved a p-value of 0.0007, with 54% of patients benefiting from 6-month dosing, while Tabirafusp-ted had a p-value of 0.0036 for vision gains. A biologics license application for Zenkuda is planned for Q4 2026, and post-hoc analyses for treatment-naïve patients are forthcoming. Both treatments demonstrated a safety profile consistent with aflibercept.