Zenkuda and tabirafusp-ted Meet Primary Endpoints in Pivotal DAYBREAK Trial in wAMD, with Zenkuda Demonstrating a Potential New Standard-of-Care Profile with Strong Immediacy and Sustained Clinical Effect with Majority of Patients on 24-week Dosing Interval Using Strict Treat-to-Dryness Real World Retreatment Criteria.

Zenkuda and tabirafusp-ted Meet Primary Endpoints in Pivotal DAYBREAK Trial in wAMD, with Zenkuda Demonstrating a Potential New Standard-of-Care Profile with Strong Immediacy and Sustained Clinical Effect with Majority of Patients on 24-week Dosing Interval Using Strict Treat-to-Dryness Real World Retreatment Criteria. PR Newswire

* 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 PALO ALTO, Calif., Sept. 28, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced 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 (wAMD). The DAYBREAK study in wAMD demonstrated that both Zenkuda and tabirafusp-ted achieved non-inferiority in vision gains compared to aflibercept at year one.