Shares of Kodiak Sciences Inc. (NASDAQ:KOD) surged about 26% on Thursday after the company reported positive topline data from GLOW2, its second Phase 3 clinical trial evaluating Zenkuda (tarcocimab tedromer) for the treatment of diabetic retinopathy.
In the study, 62.5% of patients treated with Zenkuda achieved at least a two-step improvement in their diabetic retinopathy severity score, compared with 3.3% of patients who received a sham treatment, meeting the trial’s primary endpoint with statistical significance. By the conclusion of the study, all participants were receiving the therapy on a six-month dosing schedule.
Zenkuda also demonstrated an 85% reduction in the risk of developing sight-threatening complications. Such complications occurred in 2.4% of patients treated with Zenkuda, compared with 15.8% among those receiving the sham treatment. In addition, 13.7% of patients treated with the drug achieved a three-step or greater improvement in diabetic retinopathy severity score, compared with none in the control group.
The GLOW2 trial broadened the patient population studied in the earlier GLOW1 trial by including individuals with proliferative diabetic retinopathy and mild diabetic macular edema. The study also included patients taking GLP-1 medications, with Zenkuda demonstrating similar efficacy regardless of concurrent GLP-1 therapy.
Safety findings showed no reported cases of intraocular inflammation. Cataract-related adverse events occurred in 2.3% of patients receiving Zenkuda, compared with 1.6% in the sham group. No cases of retinal vasculitis or occlusive retinal vasculitis were observed.
Following the results, Kodiak said it plans to accelerate the timeline for submitting a Biologics License Application for Zenkuda.
The company also highlighted potential implications for other pipeline therapies, including KSI-501 and KSI-101, which are currently being evaluated in separate Phase 3 trials with results expected in 2026.