STATUS: Phase I/II Active | IND# 162078 | Pivotal Study Expected 2026 [INTERESTING CALL OUT BOX OR SOMETHING]
Geographic atrophy is the most severe form of dry age-related macular degeneration and one of the most common causes of vision loss worldwide, affecting an estimated 1 million people in the US. As patches of retinal pigmented epithelium die and take the overlying sensory retina with them, patients lose central vision irreversibly. Drusen deposits in the aging retina contain amyloid-beta, complement components including C3, C5, and Factor D, and Alu RNA. These activate inflammasomes in retinal cells, releasing IL-1beta and IL-18, which drive progressive RPE and retinal cell death. Inflammasome activation is a key point of convergence in the development of both GA and wet AMD. K8 is administered as a bioerodible intravitreal implant, delivering sustained local drug release to the posterior eye without systemic exposure. A 30-patient Phase I/II dose-ranging trial across 9 US centers is underway at three dose levels, with pivotal studies anticipated in 2026.
Topline Efficacy Data - Phase I/II (January 2025) In 5 patients with bilateral geographic atrophy who received a K8 implant in one eye: Mean GA lesion growth in treated eyes was 66% less than untreated contralateral eyes at 3 months after a single implant (p=0.029) Results assessed by an independent masked reading center Good tolerability observed across the cohort Enrollment in the multicenter Phase II dose-ranging study was completed in November 2025, with further data expected. [INTERESTING CALL OUT BOX OR SOMETHING]