Palo Alto, California, U.S., September 28, 2026
Kodiak Sciences Inc. announced that both Zenkuda™ (tarcocimab tedromer) and tabirafusp alfa tedromer (tabirafusp-ted, KSI-501) met their primary endpoints in the pivotal Phase 3 DAYBREAK clinical trial evaluating patients with wet age-related macular degeneration (wAMD). Zenkuda achieved the study’s primary endpoint of non-inferiority in vision gains compared with aflibercept at one year, while demonstrating rapid retinal drying and sustained clinical effect. The company reported that 54% of patients receiving Zenkuda achieved six-month dosing durability at year one under strict treat-to-dryness retreatment criteria. Tabirafusp-ted also met its vision primary endpoint and an anatomical key secondary endpoint, providing additional clinical data for Kodiak’s retinal disease pipeline.
Zenkuda Meets Phase 3 Vision Endpoint
The DAYBREAK Phase 3 study evaluated Zenkuda and tabirafusp-ted against aflibercept in patients with treatment-naïve wAMD. Zenkuda met the primary endpoint of non-inferiority in best-corrected visual acuity, with a reported p-value of 0.0007. Kodiak also reported that Zenkuda demonstrated strong immediacy of clinical effect during the loading phase, with vision outcomes comparable to or exceeding those observed with the aflibercept comparator. These findings are important because wAMD treatment requires effective control of abnormal retinal blood-vessel growth and fluid accumulation while maintaining visual function over time. A major feature of the DAYBREAK study was its individualized treat-to-dryness dosing approach, designed to reflect real-world retinal-care practices. Zenkuda-treated patients could receive dosing at intervals ranging from four weeks to 24 weeks, depending on disease activity. Kodiak reported that 54% of patients reached a six-month dosing interval at year one, while being managed under stringent retreatment criteria requiring treatment when detectable retinal fluid was present. The company said this durability profile could potentially reduce treatment frequency for patients who maintain disease control over longer intervals.
Tabirafusp-ted Advances Dual-Target Approach
The DAYBREAK results also produced positive findings for tabirafusp-ted, an investigational bispecific therapy designed to target both IL-6 and VEGF. The candidate met its vision primary endpoint with a reported p-value of 0.0036 and achieved its anatomical key secondary endpoint with a p-value below 0.0001. Unlike Zenkuda, which is an anti-VEGF biologic, tabirafusp-ted is designed to address both VEGF-mediated vascular abnormalities and IL-6-mediated inflammation, providing a differentiated approach to retinal vascular disease. Kodiak said post-hoc analyses are planned to investigate which treatment-naïve wAMD patient subgroups may potentially benefit from IL-6 inhibition. The company is also advancing tabirafusp-ted into the Phase 3 ALTO study in diabetic macular edema, where the investigational therapy is being evaluated against aflibercept. The ALTO program is designed to explore whether dual inhibition of VEGF and IL-6 can provide additional clinical benefits in patients with diabetic macular edema, a retinal condition in which inflammation can contribute to disease progression.
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Kodiak Prepares Zenkuda Regulatory Submission
The DAYBREAK results strengthen Kodiak’s late-stage development program for Zenkuda across several retinal vascular diseases. The company said it plans to submit a multi-indication Biologics License Application (BLA) in the fourth quarter of 2026, incorporating data from five positive Phase 3 studies. These include DAYBREAK and DAYLIGHT in wAMD, GLOW1 and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion. Zenkuda is an investigational anti-VEGF biopharmaceutical built using Kodiak’s proprietary Antibody Biopolymer Conjugate (ABC®) platform. The company reports a mean ocular half-life of approximately 20 days in humans, which it says is about three times longer than approved anti-VEGF therapies. The technology is designed to combine rapid initial disease control with extended drug exposure in ocular tissues. While the DAYBREAK findings are company-reported clinical results and regulatory review remains necessary, the data provide an important late-stage milestone for Kodiak’s development strategy.
The company is also progressing its broader retinal pipeline, including KSI-101, an investigational therapy for macular edema secondary to inflammation, with Phase 3 topline data expected in December 2026. Together, the programs reflect Kodiak’s focus on developing longer-acting and multi-targeted retinal medicines for conditions that require repeated intravitreal treatment. The DAYBREAK results therefore represent a significant clinical development milestone for Zenkuda and tabirafusp-ted, while further regulatory and clinical evaluations will determine their future development and potential commercialization.
Source: Kodiak Sciences press release
