Kodiak Sciences reports GLOW2 study of Zenkuda met primary endpoint

Kodiak announced topline results in the GLOW2 Phase 3 superiority study of Zenkuda for the treatment of patients with diabetic retinopathy. In GLOW2, patients were randomized to receive either sham injection or Zenkuda via intravitreal injection at progressively extended intervals after a loading phase, with all patients on 6-month dosing by the end of the study. A total of 62.5% of patients treated with Zenkuda achieved a greater than or equal to 2-step improvement in DRSS score at Week 48, compared with 3.3% in the sham group, meeting the primary endpoint of superiority to sham with high statistical significance. Zenkuda also demonstrated superiority in the two alpha-controlled secondary endpoints, with high statistical significance: Zenkuda demonstrated superiority in the key secondary endpoint of reducing the risk of developing prespecified sight-threatening complications, including new or worsening proliferative DR or center-involving DME, by 85% compared to sham through Week 48. These results support the GLOW1 study results, in which Zenkuda reduced this risk by 89%. Overall,13.7% of patients on Zenkuda achieved a greater than or equal to3-step improvement in DRSS versus 0% with sham, an improvement comparable to GLOW1, in which 5.6% of patients on Zenkuda achieved a greater than or equal to3-step improvement in DRSS versus 0% with sham. Zenkuda was well-tolerated with low rates of common ocular adverse events. Notably, no cases of intraocular inflammation were reported in the study, and no cases of retinal vasculitis or occlusive retinal vasculitis were observed. The incidence of cataract in the study eye was low and in line with expected background rates in patients with DR. Consistent with a real-world diabetic patient population, GLOW2 included patients using GLP-1 medications. These patients were well-balanced between treatment arms. Among patients using GLP-1 medications, Zenkuda achieved a greater than or equal to 2-step improvement in DRSS from baseline to Week 48 in 60% of patients compared with 64.3% in patients not using GLP-1 medications.