Investing.com -- Kodiak Sciences Inc (NASDAQ: KOD) shares surged as much as 90% in premarket trading Monday following positive results from its Phase 3 DAYBREAK study in wet age-related macular degeneration.

The company's Zenkuda drug met its primary endpoint with a p-value of 0.0007, demonstrating vision gains and retinal drying with 54% of patients on 6-month dosing. The drug achieved non-inferiority in vision gains compared to aflibercept at year one. Tabirafusp-ted also met its vision primary endpoint with a p-value of 0.0036 and anatomical key secondary endpoint in the same study.

In the DAYBREAK study, Zenkuda demonstrated clinical effect matching or exceeding aflibercept through the loading phase. The drug showed a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate, compared to 0.9% with aflibercept. Tabirafusp-ted showed a 0.4% intraocular inflammation rate and 0% cataract adverse event rate.

The DAYBREAK study evaluated both drugs against aflibercept as an active comparator. Patients receiving Zenkuda were given individualized dosing every 4 to 24 weeks following four monthly loading doses, using a treat-to-dryness approach based on retinal fluid presence.

Kodiak also plans to report Phase 3 results from its first macular edema secondary to inflammation study of KSI-101 in December 2026. The company is advancing tabirafusp-ted in diabetic macular edema through its ongoing Phase 3 ALTO pivotal program.

Both Zenkuda and tabirafusp-ted are built on Kodiak's antibody biopolymer conjugate platform. Zenkuda has a mean ocular half-life of approximately 20 days, roughly three times longer than approved anti-VEGF therapies.

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