A preliminary phase II trial presented at the American Academy of Ophthalmology meeting found that a bioerodible implant releasing the dual inflammasome inhibitor kamuvudine K8 slowed geographic atrophy progression in patients with bilateral disease. The mid-level dose reduced lesion growth rate by 54% at six months compared with pooled control eyes, with the effect strengthening from 43% in the first three months to 70% during months three through six.
The study enrolled 30 patients, each receiving an implant in the eye with worse vision at one of three dose levels, with the fellow eye serving as control. The mid and high doses showed statistically significant slope reductions, and treated eyes gained about four letters on visual acuity in a prespecified analysis, though the trial was not powered for vision. No drug-related adverse events were reported at any dose.
Discussants noted the analysis pooled control eyes and that visual acuity testing was not masked, and the investigator acknowledged the need for a larger, longer study. Unlike approved complement inhibitors for GA, K8 blocks both NLRP3 and NLRC4 inflammasomes and is delivered as a quarterly injection requiring no refrigeration. A phase III pivotal program has been planned.