USABiotech & Genomic Medicine▲
Kodiak Sciences begins phase III ALTO study of KSI-501 for diabetic macular edema
Kodiak Sciences announced the initiation of its global late-stage ALTO study evaluating KSI-501 in patients with diabetic macular edema. The phase III trial will enroll approximately 910 patients randomized to receive either KSI-501 5 mg or Eylea 2 mg, with a primary endpoint of mean change in best-corrected visual acuity from baseline. KSI-501 is an investigational bispecific therapy targeting IL-6 and VEGF, and the study will assess whether dual inhibition can provide greater visual improvements and longer treatment durability. Top-line data from a separate phase III DAYBREAK study of KSI-501 in wet age-related macular degeneration are expected in September 2026. Year to date, Kodiak's shares have risen 55.2% compared with the industry's 6% growth.