What was the incidence of intraocular inflammation in the Phase 3 GATHER trials?

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In the Phase 3 GATHER trials, there were two cases of intraocular inflammation (IOI) in the 2 mg avacincaptad pegol (ACP) cohorts.

In GATHER1, one case of IOI (vitritis) was reported in the ACP 2 mg cohort. It was assessed as not related to ACP or injection procedure, was mild and transient in nature, and did not result in study discontinuation.¹

In GATHER2, there were no cases of IOI that occurred in Year 1 of treatment. In Year 2, one case of nonserious IOI was reported in the study eye (trace vitreous cells, moderate in severity) in the monthly ACP 2 mg cohort, though the event resolved and did not result in treatment discontinuation.²

GATHER1 and GATHER2 evaluated the safety and efficacy of ACP in patients with geographic atrophy secondary to age-related macular degeneration (AMD).^3,4

In GATHER1, one eye (n = 67; 1.5%) in the 2 mg ACP cohort developed IOI during the study, a case of vitritis, at Month 7 without any anterior chamber inflammation.¹ This event was mild with no effect on visual acuity, no treatment was given, and injections of the study drug proceeded as scheduled with complete resolution of the IOI by Month 11. The case was assessed as not related to study drug or injection procedure.
In GATHER2, there was one case of IOI (n = 1; 1%) that was non-serious that occurred in Year 2 of treatment after re-randomization of the ACP 2 mg cohort.² The AE was reported as trace vitreous cells, in the cohort that received ACP 2 mg monthly treatments (n = 96). The event resolved and the patient continued with study drug injections after AE resolution, with no additional reports of inflammation.

Patel SS, Lally DR, Hsu J, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial. Eye. 2023;37(17):3551-3557. Available at: https://doi.org/10.1038/s41433-023-02497-w.
Khanani AM, Danzig CJ, Heier JS, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 2-year efficacy and safety results from the GATHER2 phase 3 trial. Ophthalmology. 2025;epub ahead of print. Available at: https://doi.org/10.1016/j.ophtha.2025.12.011.
Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021;128(4):576-586. Available at: https://doi.org/10.1016/j.ophtha.2020.08.027.
Khanani AM, Patel SS, Staurenghi G, et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458. Available at: https://doi.org/10.1016/s0140-6736(23)01583-0.