• Phase 3 ALTO trial designed to demonstrate superiority of KSI-501 versus aflibercept in patients with diabetic macular edema

PALO ALTO, Calif., Aug. 10, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (NASDAQ:KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced that the first patients have been enrolled in the global Phase 3 ALTO trial evaluating KSI-501 in patients with diabetic macular edema (DME). KSI-501 is an investigational, first-in-class bispecific therapy built on Kodiak's ABC® Platform and designed to potently inhibit two complementary pathways implicated in retinal vascular disease: interleukin (IL)-6-mediated inflammation and vascular endothelial growth factor (VEGF)-mediated vascular permeability and neovascularization.

The ALTO trial is designed to demonstrate the superiority of bispecific (anti-VEGF, anti-IL-6) KSI-501 versus monospecific (anti-VEGF) aflibercept in patients with DME. ALTO is the second registrational Phase 3 trial of KSI-501, following the DAYBREAK study in patients with wet AMD.

ALTO explores whether dual inhibition of immune and vascular pathways can deliver deeper and more sustained disease control for patients with DME and evaluates two dosing regimens, one regimen with intensive dosing and a second regimen with individualized dosing intervals of up to every six months.