Kodiak’s Zenkuda Put 54% of Wet AMD Patients on Six-Month Dosing, Four Years After an Extended-Dosing Miss
- Kodiak Sciences said on 28 September 2026 that Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) both met the primary endpoint of non-inferior visual acuity against aflibercept at one year in the Phase 3 DAYBREAK study in wet age-related macular degeneration, with p-values of 0.0007 and 0.0036.
- 54% of Zenkuda patients were on six-month dosing under strict treat-to-dryness retreatment criteria. Tabirafusp-ted also met its anatomical key secondary endpoint (p<0.0001). Intraocular inflammation was 0% with Zenkuda and 0.4% with tabirafusp-ted.
- Kodiak plans a multi-indication BLA for Zenkuda in the fourth quarter of 2026, covering wet AMD, diabetic retinopathy and retinal vein occlusion from five Phase 3 studies. It says Zenkuda’s ocular half-life of about 20 days is roughly three times that of approved anti-VEGF drugs.
- The same molecule failed its first wet AMD trial, DAZZLE, in February 2022 when dosed every 12 to 20 weeks against aflibercept every eight weeks. It passed DAYLIGHT in 2023 only on monthly dosing, and missed in diabetic macular edema with a cataract imbalance of 19% against 9%.
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The molecule that failed on long intervals in 2022 has now held vision with most patients on six-month dosing. The durability claim is back, and so is the question that undid it before.
- Durability is the whole argument. The wet AMD market is crowded, and the FDA approved another entrant, Lytenava, in July. Vabysmo’s label extends to 16 weeks. A majority at 24 weeks is Kodiak’s claim, though 46% of patients still needed shorter intervals, so any label will cover a range.
- Check the cataracts first. The topline reports intraocular inflammation at zero, but Kodiak attributed its 2023 diabetic macular edema failures to a cataract imbalance. The full DAYBREAK cataract data will be the first number reviewers look for.
- The IL-6 bet has not paid off yet. Tabirafusp-ted adds IL-6 blockade to VEGF inhibition, and met non-inferiority, but Kodiak plans post-hoc analyses to find which patients benefit from the IL-6 component. Matching aflibercept is not enough to make the commercial case for a second mechanism.
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