Kodiak Sciences to Report Phase 3 DAYBREAK Results for Zenkuda and KSI-501

Topline Results Will Evaluate Treatments for Wet Age-Related Macular Degeneration

Kodiak Sciences Inc. (Nasdaq: KOD) has announced that it will report topline results from its Phase 3 DAYBREAK study evaluating two investigational treatments for wet age-related macular degeneration (wet AMD).

The company plans to release the results on Monday, September 28, 2026.

The study is evaluating Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) in patients with wet AMD.

Both programs are part of Kodiak Sciences’ late-stage retinal disease pipeline.

What Is Wet Age-Related Macular Degeneration?

Wet AMD is a serious eye disease that can cause vision loss.

The condition develops when abnormal blood vessels grow underneath the retina. These vessels can leak fluid or blood into the area of the eye responsible for central vision.

Over time, this leakage can damage the retina and make it difficult for patients to see clearly.

Wet AMD is one of the major causes of vision loss in older adults.

DAYBREAK Is a Phase 3 Clinical Study

DAYBREAK is a Phase 3 study designed to evaluate both Zenkuda and KSI-501 in patients with wet AMD.

Phase 3 trials are generally conducted in larger patient populations to further evaluate the safety and effectiveness of an investigational treatment before potential regulatory submissions.

The topline results are expected to provide an initial look at the findings from the DAYBREAK study.

Detailed data may provide more information about the performance and safety of the two treatments.

Zenkuda Is Being Developed for Retinal Diseases

Zenkuda, also known as tarcocimab tedromer, is one of Kodiak Sciences’ late-stage clinical programs.

The company has been developing Zenkuda for several retinal vascular diseases, including diabetic retinopathy, retinal vein occlusion and wet AMD.

Kodiak describes Zenkuda as having a BLA-ready profile in these indications.

A BLA, or Biologics License Application, is a regulatory submission used to request approval of a biological product in the United States.

KSI-501 Targets Wet AMD and Diabetic Macular Edema

KSI-501, also known as tabirafusp alfa tedromer, is another late-stage program being developed by Kodiak Sciences.

The company is evaluating KSI-501 in wet AMD and diabetic macular edema (DME).

DME is a complication of diabetes that can cause fluid to build up in the macula, the central part of the retina needed for detailed vision.

By studying KSI-501 in retinal diseases, Kodiak is working to expand its pipeline beyond a single eye condition.

Both Programs Target the Anti-VEGF Treatment Market

Kodiak Sciences says Zenkuda and KSI-501 are being developed for diseases within the anti-VEGF treatment market.

VEGF, or vascular endothelial growth factor, is a protein involved in the growth of abnormal blood vessels and leakage from blood vessels in several retinal diseases.

Anti-VEGF medicines are widely used to treat retinal vascular conditions.

According to Kodiak, Zenkuda and KSI-501 are targeting a market estimated by the company at approximately $15 billion across retinal vascular diseases.

Kodiak Is Building a Retina-Focused Pipeline

Kodiak Sciences is a pre-commercial biotechnology company focused specifically on retinal diseases.

The company is researching and developing medicines intended to prevent and treat major causes of blindness.

Its current portfolio includes three late-stage clinical programs.

Zenkuda and KSI-501 are being evaluated in retinal vascular diseases, while KSI-101 is being developed for macular edema secondary to inflammation (MESI).

KSI-101 Is Also Moving Through Phase 3 Development

KSI-101 is a bispecific protein that Kodiak is evaluating in two BLA-facing Phase 3 studies for MESI.

The company expects topline results from Pivotal Analysis 1, known as PEAK, in December 2026.

Topline results from the second pivotal analysis, PEAK plus PINNACLE, are expected in the second quarter of 2027.

These programs represent another part of Kodiak’s effort to develop treatments for different types of retinal disease.

DAYBREAK Results Could Provide Important Clinical Data

The DAYBREAK topline results will provide information on the clinical performance of Zenkuda and KSI-501 in wet AMD.

The company is expected to discuss the findings through a webcast.

The webcast can be accessed through Kodiak Sciences’ Events and Presentations page.

An archived replay will also be available for a limited period.

The detailed results from DAYBREAK will provide additional information about the safety and clinical outcomes of the two investigational treatments.

Kodiak Sciences Continues Development of Retinal Medicines

Kodiak Sciences is focused on developing next-generation retinal medicines using new approaches to drug design and manufacturing.

The company’s pipeline covers several major retinal conditions that can lead to vision loss.

As the company reports the DAYBREAK results, investors, researchers and the retinal disease community will be watching the data from Zenkuda and KSI-501.

The company also expects additional clinical milestones from its KSI-101 program in late 2026 and 2027.

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