Kodiak Sciences’ Zenkuda met the Phase 3 DAYBREAK vision endpoint in wet AMD, with 54% of patients achieving six-month dosing durability at year one.
Written By: Saniya Katakdhond, PharmD
Reviewed By: Pharmacally Editorial Team
Kodiak Sciences’ investigational Zenkuda (tarcocimab tedromer) met the primary endpoint in the Phase 3 DAYBREAK study in wet age-related macular degeneration (wAMD), demonstrating non-inferior vision gains versus aflibercept at one year while 54% of treated patients reached a six-month dosing interval under strict treat-to-dryness criteria.
DAYBREAK Delivers Non-Inferior Vision Outcomes
DAYBREAK (NCT06556368) evaluated Zenkuda and tabirafusp alfa tedromer (tabirafusp-ted, KSI-501) against aflibercept in patients with wAMD. Zenkuda met the study’s primary endpoint of non-inferiority for best-corrected visual acuity (BCVA) at one year, with a reported p-value of 0.0007.
Zenkuda also showed rapid disease control during the loading phase, with vision outcomes comparable to or exceeding those observed with aflibercept. At year one, 54% of patients achieved six-month dosing durability using proactive retreatment based on retinal fluid detected by optical coherence tomography (OCT).
ABC Platform Targets Durability
Zenkuda is an investigational anti-vascular endothelial growth factor (VEGF) therapy built on Kodiak’s antibody biopolymer conjugate (ABC) platform. The formulation combines free antibody for rapid initial activity with antibody conjugated to a high-molecular-weight biopolymer.
The approach is intended to extend drug exposure in ocular tissues. Zenkuda has a reported mean ocular half-life of approximately 20 days in humans, about three times that of approved anti-VEGF therapies.
DAYBREAK used individualized dosing from four to 24 weeks after four monthly loading doses. Retreatment relied on a treat-to-dryness strategy, with detectable retinal fluid serving as a marker of disease activity.
Safety Findings Remained Favorable
Zenkuda was well tolerated in DAYBREAK, with 0% intraocular inflammation and a 0.5% cataract adverse event rate, compared with 0.9% for cataract events in the aflibercept group. Separately, tabirafusp-ted showed a 0.4% intraocular inflammation rate and a 0% cataract adverse event rate, compared with 0.9% cataract events with aflibercept.
Tabirafusp-ted also met its vision primary endpoint, with a p-value of 0.0036, and its anatomical key secondary endpoint, with a p-value below 0.0001. The bispecific therapy targets both VEGF and interleukin-6 (IL-6), extending its biological target beyond VEGF alone.
Three-Indication BLA Planned for Zenkuda
Kodiak plans to submit a three-indication biologics license application (BLA) in the fourth quarter of 2026, covering wet AMD, diabetic retinopathy (DR), and retinal vein occlusion (RVO). The regulatory package is expected to incorporate results from five positive Phase 3 studies: DAYBREAK and DAYLIGHT in wAMD, GLOW1 and GLOW2 in DR, and BEACON in macular edema following RVO.
The broader Phase 3 program has generated additional durability findings. In GLOW1 and GLOW2, Kodiak reported that 100% of Zenkuda-treated patients were on six-month dosing at year one while preventing disease progression. In BEACON, nearly half of Zenkuda-treated patients required no treatment during the second six-month period while maintaining similar visual and anatomical outcomes to aflibercept.
Tabirafusp-ted Advances in Diabetic Macular Edema
Kodiak is continuing development of tabirafusp-ted in diabetic macular edema (DME) through the Phase 3 ALTO study, which is now enrolling patients. The global trial plans to randomize approximately 910 patients to two tabirafusp-ted dosing strategies or aflibercept.
The primary endpoint is mean change in BCVA from baseline to the average of Weeks 48 and 52. A key secondary endpoint is the proportion of patients achieving an improvement of at least two steps on the Diabetic Retinopathy Severity Scale (DRSS) at Week 48. Participants will be followed for approximately 96 weeks.
Kodiak also expects its first Phase 3 topline results for KSI-101, another retinal program targeting macular edema secondary to inflammation, in December 2026.
Reference
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, Kodiak Science, 28 September 2026
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) – DAYBREAK (DAYBREAK), ClinicalTrials.gov ID NCT06556368
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) (DAYLIGHT), ClinicalTrials.gov ID NCT04964089
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR) (GLOW), ClinicalTrials.gov ID NCT05066230
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared with Sham Treatment in Participants with Diabetic Retinopathy (DR) (GLOW2), ClinicalTrials.gov ID NCT06270836
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients with Macular Edema Due to Retinal Vein Occlusion (RVO) (BEACON), ClinicalTrials.gov ID NCT04592419
About the Writer
Saniya Sanjay Katakdhond (Linkedin) is a Doctor of Pharmacy professional with hands-on experience in patient case review, clinical documentation, medical record analysis, and patient care.
Her hospital experience has strengthened her understanding of clinical conditions, treatment approaches, and multidisciplinary healthcare practices.
With ICH-GCP certification and a research-oriented approach, she brings clinical insight and attention to detail to healthcare content development.
As a healthcare writer, Saniya focuses on translating clinical knowledge and patient-care experience into clear, accurate, and evidence-informed medical content.