Kodiak Sciences announced positive topline results from its GLOW2 phase 3 superiority study evaluating Zenkuda (tarcocimab tedromer) in patients with diabetic retinopathy (DR). Zenkuda is an investigational anti-vascular endothelial growth factor (VEGF) intravitreal biologic developed using Kodiak’s proprietary antibody biopolymer conjugate (ABC) platform, designed to enhance durability and reduce treatment burden. GLOW2 was a confirmatory phase 3 trial designed to replicate and extend the findings of the earlier GLOW1 study, which demonstrated superiority versus sham in patients with moderately severe to severe non-proliferative diabetic retinopathy. The GLOW2 trial expanded the study population to include patients with proliferative diabetic retinopathy (PDR) and mild diabetic macular edema (DME), in addition to moderately severe to severe DR. Patients were randomized to receive either sham injections or Zenkuda administered intravitreally at progressively extended dosing intervals following a loading phase. By the end of the study, all treated patients were on a 6-month dosing schedule. At Week 48, 62.5% of patients treated with Zenkuda achieved a ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score, compared to 3.3% in the sham group, meeting the primary endpoint with high statistical significance (P<0.0001). Zenkuda also met all key secondary endpoints: The therapy reduced the risk of developing prespecified sight-threatening complications—such as new or worsening proliferative DR or center-involving DME—by 85% compared to sham (2.4% vs. 15.8%, P=0.0001). This result was consistent with the 89% risk reduction observed in GLOW1. A ≥3-step improvement in DRSS was achieved in 13.7% of Zenkuda-treated patients versus 0% in the sham arm (P<0.0001), further reinforcing the drug’s efficacy. Zenkuda demonstrated a favorable safety profile in the study, with low rates of common ocular adverse events. Notably, there were no reported cases of intraocular inflammation, retinal vasculitis, or occlusive retinal vasculitis. Cataract incidence remained low and balanced between groups (2.3% for Zenkuda vs. 1.6% for sham). The study also reflected real-world patient populations, including individuals using GLP-1 medications. Outcomes were consistent regardless of GLP-1 use, with 60.0% of GLP-1 users achieving a ≥2-step DRSS improvement compared to 64.3% of non-users. “GLOW2 is unique among registration trials in including patients with center-involved DME and proliferative diabetic retinopathy,” said Charles Wykoff, MD, Chairman of Research at Retina Consultants of America and Professor of Clinical Ophthalmology at Houston Methodist Hospital, highlighted the significance of the findings. “Zenkuda demonstrated strong efficacy in this higher-risk population while enabling a six-month treatment interval, which could significantly reduce the burden of care.” Kodiak Sciences CEO Dr. Victor Perlroth stated that the company now has a “multi-indication BLA-ready profile” for Zenkuda and plans to accelerate its Biologics License Application (BLA) submission. GLOW2 is the first phase 3 study evaluating Zenkuda’s enhanced commercial formulation, which combines free and conjugated protein in a single biologic. The safety profile further supports the broader potential of Kodiak’s ABC platform. Beyond Zenkuda, the company continues to advance its pipeline, including KSI-501, a bispecific anti-IL-6/VEGF therapy, as well as other late-stage programs. Kodiak expects multiple phase 3 readouts in 2026, including the DAYBREAK, PEAK, and PINNACLE studies. Full GLOW2 results are expected to be presented at an upcoming scientific congress.