Kodiak Sciences said it has enrolled the first patients in the Phase 3 ALTO study of KSI-501 for diabetic macular edema, marking the second registrational Phase 3 program for the investigational retinal therapy after the DAYBREAK trial in wet AMD. The company said ALTO is designed to test whether KSI-501, a bispecific therapy targeting VEGF and IL-6, can outperform aflibercept, a standard anti-VEGF treatment, in patients with visual impairment from center-involved DME. The trial will enroll about 910 patients worldwide and compare two KSI-501 dosing strategies with aflibercept, including an individualized regimen that can extend to every six months after loading doses. Kodiak said the primary endpoint is mean change in best-corrected visual acuity from baseline to the average of Week 48 and Week 52, while the key secondary endpoint is a two-step or greater improvement on the DRSS (Diabetic Retinopathy Severity Scale) at Week 48. The company argues that combining inhibition of VEGF and IL-6 may improve fluid control, vision outcomes and durability by addressing both vascular leakage and inflammation, though it also said those expectations remain subject to clinical risk. Topline data from Kodiak's separate Phase 3 DAYBREAK study in wet AMD are expected in September 2026.