Kodiak’s two retinal treatments meet pivotal trial endpoints

Kodiak Sciences ($KOD) reported that Zenkuda and tabirafusp-ted met their primary vision endpoints in the Phase 3 DAYBREAK trial in wet age-related macular degeneration. Both achieved non-inferior vision gains against aflibercept at one year. Under the study’s stringent retinal-fluid retreatment criteria, 54% of Zenkuda patients reached a six-month dosing interval. Reported intraocular inflammation was 0% with Zenkuda and 0.4% with tabirafusp-ted.

The results strengthen the evidence supporting Kodiak’s planned fourth-quarter application for Zenkuda across three retinal indications, drawing on five positive Phase 3 studies. Less frequent injections could differentiate the product operationally for patients and clinics. However, non-inferiority is not proof of superior vision outcomes, the application remains planned, and neither these results nor the proposed dosing schedule constitute marketing approval.

Sources:

• Kodiak company release via PR Newswire / StockTitan