Key Takeaways

  • Both Zenkuda and tabirafusp-ted met the phase 3 DAYBREAK primary endpoints, achieving noninferiority to aflibercept for vision gains at 1 year in patients with wet AMD
  • Kodiak reported that 54% of Zenkuda-treated patients achieved a 24-week treatment interval at year 1 under strict treat-to-dryness retreatment criteria, with no intraocular inflammation reported
  • Kodiak plans a Zenkuda regulatory submission in the fourth quarter of 2026 supported by 5 positive phase 3 studies across wet AMD, diabetic retinopathy, and retinal vein occlusion

Kodiak Sciences announced positive topline results from the phase 3 DAYBREAK study, reporting that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) met the trial's primary endpoints in patients with wet age-related macular degeneration (AMD).

According to the company, both investigational therapies achieved noninferiority to aflibercept for vision gains at 1 year. Kodiak also reported that Zenkuda provided rapid clinical effects during the loading phase and enabled more than half of treated patients to reach a 6-month treatment interval.

The results add to the phase 3 dataset Kodiak plans to use in a biologics license application (BLA) for Zenkuda later in 2026.

"The strength of these DAYBREAK data positions us for the next stage of Kodiak's evolution, as we prepare for the planned commercialization of Zenkuda as a potential best-in-class therapy for patients with wet AMD, diabetic retinopathy and retinal vein occlusion," Victor Perlroth, MD, CEO of Kodiak Sciences, said in a company announcement.

DAYBREAK evaluated Zenkuda and tabirafusp-ted against aflibercept in patients with wet AMD. Kodiak reported that both investigational agents achieved noninferiority in vision gains compared with aflibercept at year 1.

For Zenkuda, the company said the treatment matched or exceeded the clinical effect of aflibercept during the loading phase. At year 1, 54% of patients treated with Zenkuda achieved a 6-month treatment interval under the study's treat-to-dryness retreatment criteria. The criteria required retreatment for detectable retinal fluid on optical coherence tomography (OCT), according to Kodiak.

"The Zenkuda results exceeded my expectations, delivering the clinical profile retina specialists are seeking: rapid vision and anatomic improvements comparable to aflibercept during loading, followed by meaningfully longer intervals between treatment for a majority of patients, while maintaining optimal fluid control," said Charles Wykoff, MD, PhD, Chairman of Research, Retina Consultants of Texas, Professor of Clinical Ophthalmology and Deputy Chair of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital. "More than half of patients reached a 24-week dosing interval using strict treat-to-dry retreatment criteria. This combination of immediacy, flexibility and true durability is unique and differentiated."

Kodiak reported that Zenkuda was generally well tolerated, with no intraocular inflammation observed in the study. Cataract adverse events occurred in 0.5% of Zenkuda-treated patients compared with 0.9% of patients receiving aflibercept.

Tabirafusp-ted also demonstrated what the company characterized as a favorable safety profile. The intraocular inflammation rate was 0.4%, and no cataract adverse events were reported, compared with a 0.9% cataract adverse event rate in the aflibercept group.

Kodiak plans to submit Zenkuda data to regulatory authorities in the fourth quarter of 2026 based on 5 positive phase 3 studies spanning 3 retinal vascular diseases.

The planned regulatory package includes DAYBREAK and DAYLIGHT in wet AMD; GLOW and GLOW2 in diabetic retinopathy; and BEACON in macular edema following retinal vein occlusion. The company said it plans to submit a BLA for Zenkuda later this year.

Zenkuda was designed to combine immediate VEGF inhibition with extended intraocular durability. According to Kodiak, the therapy combines free protein for initial disease control with antibody conjugated to a high-molecular-weight biopolymer. The company reported a mean ocular half-life of approximately 20 days in humans.

David M. Brown, MD, chief medical officer at Retina Consultants of America, said DAYBREAK's retreatment approach was designed to reflect a zero-fluid-tolerance strategy used in clinical practice.

"Those criteria also recognize that patients differ: some clear drug faster, while others sustain control much longer," Dr. Brown said. "The goal is not one-size-fits-all dosing, but extending each patient to the longest effective interval their biology allows."

Tabirafusp-ted advances in DME

The DAYBREAK findings also provide phase 3 data for tabirafusp-ted (KSI-501), a second late-stage retinal candidate in Kodiak's pipeline.

Kodiak is continuing development of tabirafusp-ted in patients with diabetic macular edema (DME) through the ongoing phase 3 ALTO pivotal program. The company is investigating whether the therapy can demonstrate superiority in DME.

A third late-stage candidate, KSI-101, is in phase 3 development for macular edema secondary to inflammation. Kodiak expects the first topline results from that program in December 2026.