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# Kodiak’s Zenkuda Posts 2nd Phase 3 Win in Diabetic Retinopathy
- URL: https://www.fdaweb.com/kodiaks-zenkuda-posts-2nd-phase-3-win-in-diabetic-retinopathy/
- Published: 2026-03-26T12:00:00.000Z
- Updated: 2026-09-14T13:36:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160885

Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retinopathy, reinforcing a dataset the company says is now ready to support a BLA.

In the GLOW2 study, 62.5% of patients treated with Zenkuda achieved at least a two-step improvement on the diabetic retinopathy severity scale (DRSS) at one year, compared to just 3.3% in the sham arm — a highly statistically significant result. The drug also showed a strong effect on disease progression. Zenkuda reduced the risk of developing sight-threatening complications by 85% versus sham, while 13.7% of treated patients achieved a three-step improvement in DRSS, compared with none in the control group.

The readout replicates findings from the earlier GLOW1 trial, but expands into a broader and more advanced patient population, including those with proliferative disease and mild diabetic macular edema.

A key differentiator for Zenkuda is durability, the company says. By the end of the study, all patients were maintained on 6-month dosing intervals, following an initial loading phase — a schedule that, if approved, could address one of the biggest limitations of current anti-VEGF therapies: frequent intravitreal injections.

Kodiak also emphasizes that efficacy was consistent regardless of concurrent use of GLP-1 drugs, which are increasingly common in diabetic populations and have raised questions about potential interactions in retinal disease.

The company said the combined GLOW1 and GLOW2 data give Zenkuda a “multi-indication BLA-ready profile,” and it plans to accelerate its regulatory filing timeline.

Zenkuda is built on Kodiak’s antibody biopolymer conjugate platform, designed to extend drug durability in ocular tissues. The next key catalyst will come later this year, when Kodiak expects Phase 3 data from the DAYBREAK study in wet age-related macular degeneration, which could further define the drug’s commercial potential across retinal diseases.