Key Highlights
- Zenkuda successfully achieved its primary endpoint in the GLOW2 Phase 3 clinical trial for diabetic retinopathy
- Treatment group showed 62.5% success rate in achieving target improvement compared to 3.3% in control group
- An 85% reduction in sight-threatening complications was observed versus control through Week 48
- Trial demonstrated zero instances of intraocular inflammation
- Company to fast-track its Biologics License Application filing based on positive results
Shares of Kodiak Sciences (KOD) climbed to $22.75 on the announcement, continuing a remarkable 656% surge over the previous twelve months, despite showing an 18.6% decline in 2025.
Kodiak Sciences announced successful outcomes from its GLOW2 Phase 3 clinical trial evaluating Zenkuda (tarcocimab tedromer) for diabetic retinopathy treatment.
The data, unveiled on March 26, demonstrated superior performance compared to control across all evaluated metrics.
Patients receiving Zenkuda achieved two-step or greater improvement in diabetic retinopathy severity score (DRSS) at Week 48 in 62.5% of cases. The control group managed only a 3.3% success rate on the same measure.
This outcome achieved statistical significance, meeting the primary endpoint with robust confidence intervals.
Vision-Threatening Event Reduction
The treatment demonstrated an 85% reduction in risk for developing prespecified vision-threatening events compared to control through the 48-week period. These events encompassed new or worsening proliferative diabetic retinopathy or center-involving diabetic macular edema.
Merely 2.4% of patients on Zenkuda experienced such complications, contrasted with 15.8% in the control cohort.
Regarding secondary endpoints, 13.7% of the Zenkuda cohort demonstrated three-step or greater DRSS improvement versus zero patients in the control group.
These findings align with the preceding GLOW1 trial, which showed an 89% reduction in sight-threatening complications with Zenkuda.
GLOW2 served as a confirmatory investigation to GLOW1 and broadened enrollment criteria to encompass patients with proliferative diabetic retinopathy and mild diabetic macular edema.
Participants received Zenkuda administrations at study initiation, Week 4, Week 8, Week 20, and Week 44. By trial conclusion, all subjects were maintained on 6-month dosing intervals.
Tolerability Data
The treatment demonstrated favorable tolerability characteristics. Zero instances of intraocular inflammation emerged during the study period, and no cases of retinal vasculitis or occlusive retinal vasculitis were documented.
Cataract-related adverse events occurred in 2.3% of Zenkuda recipients versus 1.6% in controls — consistent with anticipated baseline rates among diabetic retinopathy populations.
GLOW2 enrolled patients receiving GLP-1 receptor agonist therapy, mirroring actual clinical populations with diabetes. Approximately 46.1% of the Zenkuda cohort and 42.4% of controls were receiving GLP-1 medications.
Among Zenkuda recipients using GLP-1 therapy, 60.0% achieved the primary endpoint, compared with 64.3% of non-GLP-1 users — a minimal variance indicating GLP-1 use didn’t substantially influence treatment response.
The company announced plans to expedite its Biologics License Application submission for Zenkuda following the encouraging GLOW2 outcomes.
H.C. Wainwright maintains a Buy recommendation on KOD stock with a $38 price objective. UBS similarly holds a Buy rating with a $50 target.
