The ALTO study evaluates KSI-501, an investigational bispecific therapy designed to target both interleukin-6-mediated inflammation and VEGF-driven vascular leakage. By addressing these two distinct biological pathways, Kodiak researchers hope to provide more robust disease control for patients who experience persistent fluid or incomplete visual recovery under conventional anti-VEGF monotherapy.
Kodiak Sciences Launches Phase 3 Trial for Diabetic Macular Edema Drug
Kodiak Sciences has begun enrolling patients in its global Phase 3 ALTO trial, a clinical study testing the efficacy of KSI-501 against the current standard of care, aflibercept, in treating diabetic macular edema. The trial aims to validate whether dual inhibition of inflammation and vascular growth offers superior vision outcomes.
The trial will involve approximately 910 participants, who will be randomized into three arms to compare different dosing regimens, including individualized intervals stretching up to six months. Beyond the primary endpoint of changes in best-corrected visual acuity, the study is powered to measure improvements on the Diabetic Retinopathy Severity Scale. This trial follows the company's previous Phase 2 studies, which suggested that combining immune and vascular pathway inhibition could yield synergistic benefits for patients suffering from retinal vascular disease.
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