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Phase III Success Pushes Kodiak’s Eye Treatment Towards Approval
Kodiak said 54% of Zenkuda patients reached a six-month dosing interval, while both drugs matched aflibercept on vision gains.
On Monday, Kodiak Sciences announced positive Phase III results from the DAYBREAK study, evaluating Zenkuda and tabirafusp-ted in 690 patients with wet age-related macular degeneration.
Current Wet AMD treatments like Eyelea and Vabysmo require injections every four to eight weeks; Zenkuda is designed to remedy this burden by extending the interval between treatments.
Data from DAYBREAK shows 54% of patients achieved a 6-month dosing interval by year one, with Zenkuda efficacy matching Eyelea when using optical coherence tomography guidance for retreatment decisions.
Chief medical officer J. Pablo Velazquez-Martin said the study demonstrated "rapid disease control in wet AMD and the potential for six-month durability," validating Kodiak's design strategy for Zenkuda.
Kodiak plans to submit Zenkuda for FDA approval across three indications—wet AMD, diabetic retinopathy, and macular edema—in the coming months based on five positive Phase III trials.