Kodiak Sciences Reports Positive Phase 3 Results for Zenkuda and KSI-501

In the DAYBREAK study, 54% of patients treated with Zenkuda achieved a six-month dosing interval, adhering to strict treat-to-dryness criteria. The therapy demonstrated strong immediacy of clinical effect, matching the performance of the aflibercept comparator during the initial loading phase. Safety profiles for both investigational drugs remained consistent with established standards, showing low rates of ocular inflammation and cataract adverse events.

Following these results, Kodiak Sciences plans to submit a biologics license application for Zenkuda in the fourth quarter of 2026, covering three major retinal vascular diseases. Meanwhile, the company is accelerating the development of tabirafusp-ted, which also met its primary vision and anatomical endpoints in the trial. Enrollment is currently underway for the ALTO Phase 3 study, designed to evaluate the bispecific therapy’s potential superiority in treating diabetic macular edema. CEO Victor Perlroth noted that these clinical milestones reinforce the company's objective to build a portfolio of durable, long-acting retinal medicines.