ASRS 2026: K8 slows geographic atrophy lesion growth up to 54% in phase 2

Quarterly intravitreal kamuvudine-8 (K8; Inflammasome Therapeutics) reduced geographic atrophy (GA) lesion growth by 54% in the 0.7-mg cohort and produced a visual acuity advantage over 6 months in a phase 2 trial (NCT06164587).^1,2 Jayakrishna Ambati, MD, of the University of Virginia in Charlottesville, reported the findings at the 44th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) in Montréal, Québec, Canada.¹

K8 is an investigational dual inflammasome inhibitor delivered as a bioerodible sustained-release intravitreal implant. The trial enrolled 30 patients with bilateral GA across 9 US clinical centers, representing 60 eyes. The worse-seeing eye of each participant received 1 of 3 doses—0.3, 0.7, or 1.05 mg—while the fellow eye remained untreated and contributed to a pooled control group.¹ Participants received an implant at baseline and a second injection at month 3. Masked readers at an independent reading center graded the imaging.¹

How effective was K8 over 6 months?

The 0.7-mg cohort showed a 54% lower mean rate of GA growth than pooled control eyes over 6 months (P = .016) using the FDA-preferred linear mixed-effects slope model. A prespecified analysis of eyes with extrafoveal lesions showed a covariate-adjusted 4.0-letter mean best-corrected visual acuity (BCVA) advantage for the K8-treated group overall versus control (P = .004), in an analysis of 14 treated and 16 untreated eyes. That adjustment accounted for lesion growth rate, lesion focality, and low-luminance deficit.² Eyes with subfoveal lesions showed no significant BCVA effect.¹

"This is perhaps the first time in a phase two study, certainly within the first six months, that we have seen both structural and functional benefit," Ambati told Modern Retina.

Ambati is director of the Center for Advanced Vision Science and the DuPont Guerry III professor of ophthalmology at the University of Virginia. He is also the founder of Inflammasome Therapeutics, which is developing K8.²

What did the safety profile show?

No drug-related serious adverse events or dose-limiting toxicities occurred through month 6. Investigators reported no endophthalmitis, intraocular inflammation, neovascular age-related macular degeneration, retinal vasculitis, or optic neuropathy. Ambati said the main drug-attributable finding was subconjunctival hemorrhage, which he characterized as primarily injection-related. The most common drug-attributable finding was subconjunctival hemorrhage, which Ambati characterized as primarily injection-related.

What could differentiate K8 in practice?

Ambati pointed to durability and delivery as further points of contrast. The study regimen administered K8 once every 3 months rather than monthly, and the small molecule requires no refrigeration or cold-chain storage. It is supplied in a 24-gauge preloaded injector for in-office administration, avoiding withdrawal from a vial.² Reductions in lesion growth appeared within the first 3 months, he said. A global phase 3 pivotal program is planned, and the company said it will seek regulatory input before proceeding.²

References
1. Ambati J. A Phase 2 Clinical Trial of the Inflammasome Inhibitor K8 in Bilateral Geographic Atrophy (GA). Presented at: American Society of Retina Specialists 44th Annual Scientific Meeting; July 15-18, 2026; Montréal, Québec, Canada.
2. Inflammasome Therapeutics reports positive six-month phase 2 results for K8 in geographic atrophy. News release. Inflammasome Therapeutics. July 17, 2026. Accessed July 23, 2026. https://inflam.com/inflammasome-therapeutics-reports-positive-six-month-phase-2-results-for-k8-in-geographic-atrophy