Kodiak Sciences Inc. shares climbed 26% on Thursday following the announcement of positive topline results from GLOW2, the companys second Phase 3 trial of Zenkuda (tarcocimab tedromer) for the treatment of diabetic retinopathy.
The trial achieved its primary endpoint, with 62.5% of patients treated with Zenkuda recording a two-step or greater improvement in diabetic retinopathy severity score, compared with 3.3% of patients receiving sham treatment. Kodiak reported that this result reached statistical significance. By the end of the study, all participants were maintained on a six-month dosing interval.
Beyond the primary endpoint, the company reported an 85% reduction in the risk of developing sight-threatening complications among Zenkuda-treated patients: 2.4% of those on Zenkuda experienced such complications versus 15.8% in the sham group. The drug also produced larger gains on a more stringent measure of disease reversal, with 13.7% of treated patients achieving a three-step or greater improvement in diabetic retinopathy severity score compared to 0% in the sham arm.
GLOW2 broadened patient eligibility relative to the earlier GLOW1 study to include individuals with proliferative diabetic retinopathy and those with mild diabetic macular edema. The protocol also enrolled patients taking GLP-1 medications; Kodiak stated that Zenkuda demonstrated similar efficacy irrespective of concomitant GLP-1 use.
On safety, Kodiak reported no cases of intraocular inflammation and no instances of retinal vasculitis or occlusive retinal vasculitis in the study. Cataract adverse events were observed at a rate of 2.3% among Zenkuda-treated patients versus 1.6% in the sham group.
Following these topline data, Kodiak said it intends to accelerate the submission timeline for a Biologics License Application for Zenkuda. The company also emphasized that the positive GLOW2 results have favorable implications for other pipeline candidates. Specifically, Kodiak cited KSI-501 and KSI-101, which are undergoing separate Phase 3 evaluations and are scheduled to have readouts in 2026.
Context and implications
The GLOW2 results provide the company with clinical endpoints used to support regulatory filings and may influence investor perceptions of Kodiaks late-stage ophthalmology portfolio. The trials inclusion of patients with proliferative disease and those on GLP-1 therapy offers a broader efficacy data set than the earlier study.
Data limitations
These are topline results from a single Phase 3 study. Kodiaks public statement outlines the key efficacy and safety measures reported, and the company has announced plans to move toward a Biologics License Application submission based on these data.