Kodiak’s Zenkuda meets primary endpoint in wet AMD trial

Palo Alto, California - Kodiak Sciences Inc., a biopharmaceutical company, announced that its experimental drug Zenkuda met the primary endpoint in a Phase 3 wet age-related macular degeneration study, according to a press release. In the DAYBREAK trial, Zenkuda showed non-inferiority to aflibercept in terms of vision improvement after one year, with a statistical significance of 0.0007.

Zenkuda allowed 54% of patients to extend the dosing interval to six months, following a strict retreatment criterion. The drug demonstrated a very low rate of intraocular inflammation (0%) and cataract adverse events (0.5%), compared to aflibercept, with rates of 0.9% and 0.9%, respectively. Another investigational drug, tabirafusp alfa tedromer, also met its vision improvement primary endpoint with a statistical significance of 0.0036 and a secondary anatomical endpoint with a p-value less than 0.0001. This drug also showed a low rate of intraocular inflammation (0.4%) and no cataract adverse events.

Kodiak plans to submit a biologics license application for Zenkuda in the fourth quarter of 2026, incorporating data from five Phase 3 studies in wet age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion. The DAYBREAK study compared both Zenkuda and aflibercept against aflibercept as the active comparator.

Patients on the Zenkuda arm received personalized dosing every four to 24 weeks, based on a treat-to-dryness approach utilizing retinal fluid as a disease marker. With a mean ocular half-life of 20 days, Zenkuda is three times longer-lasting than current anti-VEGF therapies.

Kodiak revealed it anticipates to disclose early-stage results for another drug, KSI-101, in December 2026 for treating macular edema due to inflammation. This report was created with AI assistance and reviewed by an editor.