Kodiak Sciences Advances Phase 3 Trial for Macular Edema Treatment

The PEAK trial targets macular edema secondary to inflammation, or MESI, a condition characterized by fluid accumulation and visual impairment that currently lacks approved intravitreal biologic therapies. By focusing on this specific patient population, Kodiak aims to provide an alternative to traditional corticosteroid treatments, which are often associated with elevated intraocular pressure and cataract risks. Data from the earlier Phase 1b APEX study suggested that KSI-101 could improve visual acuity and normalize retinal architecture, providing the foundation for the current registrational efforts.

Beyond the first cohort, the company is conducting a broader assessment through the combined PEAK and PINNACLE studies, which collectively aim to enroll 600 patients across varying disease severities. Enrollment for this second stage is expected to conclude in the fourth quarter of 2026, with findings anticipated in the second quarter of 2027. According to Chief Medical Officer J. Pablo Velazquez-Martin, the primary goal is to address the limitations of existing systemic therapies while mitigating potential toxicities for patients at high risk of vision loss.