Kodiak Sciences Inc. announced that the primary endpoints were met for both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) in the phase 3 DAYBREAK study in patients with wet age-related macular degeneration (AMD). The DAYBREAK study demonstrated that both Zenkuda and tabirafusp-ted achieved noninferiority in vision gains compared with aflibercept 2 mg (Eylea; Regeneron) at 1 year, the company said in a press release. 

According to Kodiak Sciences, Zenkuda demonstrated strong immediacy of clinical effect, matching and/or exceeding that of the aflibercept comparator through the loading phase. Zenkuda also demonstrated strong durability of clinical effect, with 54% of patients achieving 6-month durability at 1 year, while employing strict treat-to-dryness real-world retreatment criteria.

In addition, the company said Zenkuda demonstrated favorable safety and was well tolerated in the study with a 0% intraocular inflammation rate and a 0.5% cataract adverse event rate (vs 0.9% with aflibercept comparator). Tabirafusp-ted also demonstrated favorable safety and was well tolerated in the study with a 0.4% intraocular inflammation rate and a 0% cataract adverse event rate (vs 0.9% with aflibercept).

Kodiak said it plans to submit Zenkuda data to regulatory authorities in the fourth quarter of 2026 from 5 positive phase 3 studies: DAYBREAK and DAYLIGHT in wet AMD, GLOW and GLOW2 in diabetic retinopathy, and BEACON in macular edema following retinal vein occlusion. RP