Kodiak Sciences Inc. (KOD) reported positive topline results from its GLOW2 Phase 3 study of Zenkuda, an investigational anti-VEGF eye therapy designed to slow or reverse damage caused by diabetic retinopathy- a progressive condition in which leaking blood vessels harm the retina and can lead to vision loss.
Zenkuda (tarcocimab tedromer) is built on Kodiak's Antibody Biopolymer Conjugate (ABC) platform, which is designed to keep drug levels in the eye longer, allowing for extended dosing intervals. The therapy has already delivered positive results across multiple late-stage trials.
The new GLOW2 study confirmed and strengthened findings from the earlier GLOW1 trial.
In GLOW2, 62.5% of patients treated with Zenkuda achieved a two-step or greater improvement on the Diabetic Retinopathy Severity Scale at Week 48, compared with just 3.3% of patients receiving sham treatment. The therapy also reduced the risk of developing sight-threatening complications- including proliferative diabetic retinopathy and center-involving macular edema- by 85% versus sham.Both GLOW1 and GLOW2 used extended-interval dosing, with all Zenkuda-treated patients reaching a six-month dosing schedule by the end of the first year. GLOW1 first demonstrated that Zenkuda could improve disease severity and prevent progression with just four injections in year one; GLOW2 replicated these results in a broader patient population.
Zenkuda also showed consistent efficacy regardless of whether patients were using GLP-1 medications, reflecting real-world treatment patterns.
Safety results were favorable, with no cases of intraocular inflammation or retinal vasculitis reported, and cataract rates remained low and comparable to sham. Investigators highlighted the therapy's durability and the advantages of its ABC-based design.Kodiak said the combined strength of GLOW1 and GLOW2 supports plans to accelerate regulatory submissions for Zenkuda.
The company is also advancing other ABC-based programs:
-KSI-501, a bispecific anti-IL-6/VEGF-trap ABC biologic in Phase 3, is being developed for wet AMD and diabetic macular edema. The DAYBREAK study- the final planned Phase 3 trial in wet AMD- has completed enrolment. Patients receive dosing every 1 to 6 months based on an AI-driven assessment of disease activity. Topline results are expected in the third quarter of 2026, supporting a potential BLA submission if successful.
-KSI-101, a small-molecule ABC conjugate in Phase 3, is being developed for Macular Edema Secondary to Inflammation (MESI) and other retinal inflammatory and vascular conditions. The PEAK and PINNACLE Phase 3 studies are actively recruiting, with pivotal analysis 1 for PEAK expected in the fourth quarter of 2026, which could support a potential BLA submission.
When we alerted our readers to KOD on September 23, 2025, it was trading at $15.01.
The stock is currently trading at $37.28, up 64.29%, touching a new 52-week high.
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