Can ACP be administered every other month?

EOM efficacy results

• ACP 2 mg met the prespecified primary efficacy endpoint, reducing the mean rate of GA growth (slope; square root transformation) at Year 1 as measured by FAF.¹  The reduction in the mean rate of GA growth at Year 1 was 14.3% (difference: 0.056 mm/year [95% CI 0.016, 0.096]; p = 0.0064) for ACP 2 mg compared with sham.
• Over two years, both ACP 2 mg every month (EM) and EOM reduced the mean rate of GA growth by 14.0% (difference: 0.724 mm²; p = 0.0165) and 19% (difference: 0.976 mm²; nominal p = 0.0015), respectively, compared with sham (Figure 1).² 

Figure 1. GA growth over time at Year 2 using a slope analysis (re-randomized analysis set)²  

^ap-value is nominal. Note: This analysis is based on a mixed model assuming constant growth rate from baseline to Year 2. The ACP 2 mg EOM group received monthly ACP 2 mg in the first year (ACP 2 mg EM to EOM).

Adapted from: Khanani AM et al., Ophthalmology 2025.

• Treatment effect more than doubled with ACP 2 mg EM and EOM over 24 months compared to the treatment effect over 12 months (Figure 2).

Figure 2. Change in GA growth (piecewise analysis)²

Note: This is a simplified piecewise slope spline multivariate and repeated measures analysis.
This analysis is based on a mixed effects model for repeated measures assuming a piecewise linear growth slope every six months. The model included effects for treatment, time, and time-by-treatment interaction.
The ACP 2 mg EOM group received monthly ACP 2 mg in the first year (ACP 2 mg EM to EOM).

Adapted from: Khanani AM et al., Ophthalmology 2025.

Subgroup analysis² 

• In a prespecified subgroup analysis on patient and lesion baseline characteristics, treatment effect was consistently noted for ACP 2 mg EOM over two years compared with sham (Figure 3).

Figure 3. GA growth rate by demographics and clinical characteristic subgroups² 

The ACP 2 mg EOM group received monthly ACP 2 mg in the first year (ACP 2 mg EM to EOM).
Adapted from: Khanani AM et al., Ophthalmology 2025.

EOM safety results

• In GATHER2 at Month 12, the most frequently reported AEs (> 5%) were conjunctival hemorrhage, increased intraocular pressure, choroidal neovascularization (CNV), conjunctival hyperemia, and punctate keratitis.¹  Treatment emergent adverse events (TEAEs) over two years were similar, and no new safety signals were identified compared with Year 1. Table 1 presents a summary of serious ocular TEAEs, adverse events of special interests, and CNV for both ACP 2 mg EM and EOM in the study eye over the 2year period.² 

Table 1. Summary of serious ocular TEAEs and AEs of special interest² 

Adapted from: Khanani AM et al., Ophthalmology 2025.

1. 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.

2. 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.