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Article | 2026 AAO Meeting

K8 Shows Greater GA Growth Reduction Over Time

Liangbo Shen, MD, reported additional phase 2 findings at AAO 2026 as Inflammasome Therapeutics prepares for a phase 3 trial.

By: Jim Gallagher, senior managing editor
Retinal Physician October 10, 2026
Objective:

Report additional phase 2 findings on intravitreal kamuvudine K8 for geographic atrophy (GA), including lesion growth, visual acuity, and safety.

Approach:
  • Study design: Six-month, multicenter US study of 30 patients with bilateral GA at 9 centers. K8 was given to the worse-seeing eye at baseline and month 3; the untreated fellow eye served as control.
  • Dosing and assessment: Treated eyes were assigned to 0.3-mg, 0.7-mg, or 1.05-mg cohorts (10 eyes each). Masked readers assessed GA lesion growth; analyses accounted for the paired-eye design.
Key Findings:
  • In the primary analysis, K8 0.7 mg reduced GA growth rate by 54% versus control eyes. Twenty-five of 30 participants had slower progression in the treated eye.
  • The 0.7-mg and 1.05-mg cohorts had statistically significant reductions in progression; the 0.3-mg cohort showed a numerical trend favoring treatment.
  • In a piecewise analysis of the 0.7-mg cohort, growth was reduced by 43% during months 0–3 and 70% during months 3–6; the overall reduction was 56% (P=.0084).
  • In a prespecified nonsubfoveal GA subgroup, covariate-adjusted BCVA favored K8 by 4 letters (14 treated and 16 control eyes; P=.004). The study was not powered to assess visual acuity.
  • Through month 6, no drug-related serious adverse events or dose-limiting toxicities were reported. Investigators reported no endophthalmitis, intraocular inflammation, neovascular AMD, retinal vasculitis, or optic neuropathy.
Interpretation:

The phase 2 analyses showed reduced GA lesion growth with K8, with a larger estimated reduction during months 3–6 than during months 0–3. Dr. Shen said larger and longer studies are needed to assess the increasing effect and validate functional benefits.

Limitations:
  • The study included only 30 participants and lasted 6 months.
  • The study was not powered to evaluate visual acuity outcomes.
  • The small population limits conclusions about uncommon adverse events.
Conclusion:

Inflammasome Therapeutics is planning a global phase 3 pivotal trial to further evaluate K8 in GA.