Kodiak Sciences Inc. (NASDAQ:KOD) on Monday released data from the Phase 3 DAYBREAK trial for patients suffering from wet age-related macular degeneration (wAMD).
The study showed that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) achieved their primary endpoints.
DAYBREAK Trial Results
The study demonstrated that Zenkuda and tabirafusp-ted provided non-inferior vision gains compared to Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea (aflibercept) after one year.
Zenkuda showed a strong, immediate clinical effect during the initial treatment phase, comparable to or exceeding aflibercept.
It also exhibited lasting results, with 54% of patients maintaining vision improvements for six months at the one-year mark.
Safety and Future Plans
Both Zenkuda and tabirafusp-ted were well-tolerated and demonstrated favorable safety profiles.
Zenkuda reported a 0% rate of intraocular inflammation and a 0.5% rate of cataract adverse events, lower than the 0.9% seen with aflibercept.
Tabirafusp-ted showed a 0.4% intraocular inflammation rate and no cataract adverse events.
Kodiak Sciences intends to submit a multi-indication biologics license application (BLA) for Zenkuda to regulatory agencies in the fourth quarter of 2026.
This submission will include data from five Phase 3 studies: DAYBREAK and DAYLIGHT for wAMD, GLOW and GLOW2 for diabetic retinopathy, and BEACON for macular edema associated with retinal vein occlusion.
The company will also conduct further analyses to determine which previously untreated wAMD patients might benefit most from IL-6 inhibition.
Development of tabirafusp-ted is accelerating for diabetic macular edema, with active enrollment underway for the ALTO Phase 3 study.
KOD Price Action: Kodiak Sciences shares were up 137.09% at $76.70 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
Photo Courtesy: Monkey Business Images on Shutterstock
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