Kodiak Sciences reported positive topline results from the phase 3 GLOW2 trial evaluating Zenkuda (tarcocimab tedromer; formerly KSI-301) for diabetic retinopathy (DR), demonstrating superiority over sham across primary and key secondary endpoints.

In the randomized, sham-controlled study, 62.5% of treated patients achieved a ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score at 48 weeks, compared with 3.3% in the sham group (P<.0001). The therapy also reduced the risk of sight-threatening complications by 85% (2.4% vs 15.8%; P=.0001) and produced ≥3-step DRSS improvements in 13.7% of treated eyes vs none in the control group.

GLOW2 included a broader population than prior studies, enrolling patients with proliferative disease and mild diabetic macular edema. All treated patients were extended to 6-month dosing intervals following a loading phase.

Safety findings were consistent with prior studies. No cases of intraocular inflammation, retinal vasculitis, or occlusive vasculitis were reported. Cataract adverse events occurred in 2.3% of treated eyes and 1.6% of sham-treated eyes.

Efficacy appeared similar regardless of concomitant use of GLP-1 receptor agonists, with comparable DRSS improvement rates between subgroups.

The results build on findings from the earlier phase 3 GLOW1 study and support a planned biologics license application submission, company officials said in a press release.

Zenkuda is also being studied for retinal vein occlusion (in the phase 3 BEACON trial) and neovascular age-related macular degeneration (in the phase 3 DAYBREAK trial). RP