Kodiak Sciences (Nasdaq: KOD) reported that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (tabirafusp alfa tedromer) met their primary endpoints in the Phase III DAYBREAK trial in wet age-related macular degeneration (wAMD), with Kodiak planning a multi-indication biologics license application for Zenkuda in Q4 2026.
The randomized, double-masked study compared both agents with aflibercept in treatment-naïve wAMD patients, with non-inferiority in best-corrected visual acuity change through Year 1 as the primary endpoint. Zenkuda met the endpoint with a p-value of 0.0007, while tabirafusp-ted met it with a p-value of 0.0036 and also met a key anatomical secondary endpoint (p<0.0001).
Kodiak said 54% of Zenkuda-treated patients reached a 24-week dosing interval at Year 1 under treat-to-dryness retreatment criteria requiring retreatment for any detectable retinal fluid.
Zenkuda is an anti-VEGF antibody biopolymer conjugate developed on Kodiak's ABC platform, while tabirafusp-ted combines VEGF inhibition with IL-6 blockade. Safety for both agents was generally consistent with aflibercept, with no new safety findings reported.