Kodiak Zenkuda Phase 3 results showed that both Zenkuda and tabirafusp-ted met the primary vision endpoints in the pivotal DAYBREAK study for wet age-related macular degeneration, according to topline data reported by Kodiak Sciences (NASDAQ: KOD).
Both investigational therapies achieved non-inferiority to aflibercept in vision gains after one year. The trial enrolled approximately 690 patients, but the company has not yet published the complete dataset in a peer-reviewed journal.
Kodiak Zenkuda Phase 3 Results Support Longer Dosing
Zenkuda met its primary endpoint with a reported p-value of 0.0007. Kodiak said 54% of treated patients reached six-month, or 24-week, dosing at one year under strict treat-to-dry criteria in its official clinical update.
A longer interval between eye injections could reduce the treatment burden for patients if efficacy and safety are confirmed through regulatory review. The dosing result is therefore commercially important, but it does not mean every patient can remain on a six-month schedule.
Tabirafusp-ted also met its vision endpoint, with a p-value of 0.0036, and achieved a key anatomical endpoint with a p-value below 0.0001. Kodiak is developing the two medicines as distinct antibody-biopolymer conjugates.
Regulatory Filing Is Planned for the Fourth Quarter
Kodiak said the safety findings were consistent with aflibercept. Reported intraocular inflammation was 0% in the Zenkuda arm and 0.4% with tabirafusp-ted, while cataract rates were 0.5% and 0%, respectively. Aflibercept’s cataract rate was 0.9% in the study.
The company plans to submit a biologics license application for Zenkuda in the fourth quarter of 2026. That filing is expected to include data from five positive Phase 3 studies across wet AMD, diabetic retinopathy and retinal vein occlusion.
Zenkuda and tabirafusp-ted remain investigational and are not approved for commercial use. The Food and Drug Administration will independently evaluate the benefit-risk profile, manufacturing information and completeness of the application.
More detailed DAYBREAK results, the filing itself and any FDA acceptance decision are the next milestones. Those steps will show whether the topline efficacy and dosing claims hold up under fuller review.
