Kodiak reports Phase 3 Zenkuda AMD trial results
- Kodiak Sciences reported that Zenkuda and tabirafusp-ted met primary vision endpoints in the Phase 3 DAYBREAK wet AMD trial.
- Both treatments achieved non-inferior vision gains compared with aflibercept at one year, with reported p-values of 0.0007 and 0.0036.
- Kodiak said it plans to submit a Zenkuda biologics license application in the fourth quarter of 2026.
Kodiak Sciences (NASDAQ:KOD) reported that Zenkuda and tabirafusp-ted met primary vision endpoints in the Phase 3 DAYBREAK trial evaluating treatments for wet age-related macular degeneration.
The study showed both investigational treatments achieved non-inferior vision gains compared with aflibercept after one year, with Zenkuda’s primary endpoint reaching a p-value of 0.0007 and tabirafusp-ted’s reaching a p-value of 0.0036.
Kodiak reported that tabirafusp-ted also met a key retinal-anatomy endpoint with a p-value below 0.0001, while 54% of Zenkuda patients reached a 24-week dosing interval at year one under retreatment criteria based on detectable retinal fluid.
Kodiak Sciences develops treatments for retinal diseases, including therapies designed to address conditions affecting vision and eye health.
The company said it plans to submit a Zenkuda biologics license application in the fourth quarter of 2026 covering wet AMD, diabetic retinopathy, and macular edema following retinal vein occlusion, based on data from five Phase 3 studies.
