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Home > Geographic Atrophy > Two-year GATHER2 data show sustained GA growth reduction with avacincaptad pegol

Two-year GATHER2 data show sustained GA growth reduction with avacincaptad pegol

Ophthalmology 360

Key Takeaways

  1. Avacincaptad pegol 2 mg reduced geographic atrophy growth compared with sham over two years with both monthly and every-other-month dosing.
  2. Patients continuing avacincaptad pegol in Year 2 showed reduced GA growth with either monthly or every-other-month treatment schedules.
  3. Over 2 years, the safety profile was consistent with Year 1, with no cases of retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation.

In the Phase 3 GATHER2 trial, avacincaptad pegol (ACP) 2 mg given either monthly or every other month was associated with reduced geographic atrophy (GA) growth compared with sham over 2 years, according to a study.

In GATHER2 a total of 447 patients were enrolled and randomized 1:1 to receive monthly intravitreal ACP 2 mg (n = 225) or sham (n = 222) for the first year. At Month 12, patients initially treated with ACP who completed Year 1 were re-randomized to either monthly dosing (every month [EM]; n = 96) or every-other-month dosing (EOM; n = 93) for Year 2. Patients originally assigned to sham continued sham treatment (n = 203).

By Year 2, 175 patients in the ACP group and 184 patients in the sham group completed the study. Over the 2-year period, both ACP dosing regimens were associated with reduced GA growth compared with sham. From baseline to Year 2, geographic atrophy grew more slowly in patients treated with avacincaptad pegol than in those who received sham. Mean GA growth was 4.46 mm² with monthly dosing and 4.20 mm² with every-other-month dosing, compared with 5.18 mm² in the sham group. This translated to a 14% reduction in GA growth with monthly dosing and a 19% reduction with every-other-month dosing versus sham.

Over two years, ocular treatment-emergent adverse events in the study eye were reported in 64.0% of patients treated with ACP (all treated) and 48.2% of patients in the sham group. Choroidal neovascularization occurred in 11.6% of ACP-treated patients compared with 9.0% of sham-treated patients. No cases of retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation were reported during the 2-year study period.

Reference

Khanani AM, Danzig CJ, Heier JS, et al; GATHER2 trial investigators. 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;S0161-6420(25)00790-0. doi: 10.1016/j.ophtha.2025.12.011. Epub ahead of print. PMID: 41407269.

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