Intravitreal avacincaptad pegol demonstrates promising results for geographic atrophy
Intravitreal avacincaptad pegol (ACP) has shown promising results in two Phase 3 pivotal trials for the treatment of geographic atrophy (GA), a progressive and vision-threatening eye disease, according to data presented at ASRS 2023.
ACP, a pegylated RNA aptamer that inhibits complement C5, demonstrated a significant reduction in the progression of GA compared to sham treatment over a 12-month period. The safety profile of ACP was also found to be consistent and manageable.
The 2 trials, GATHER1 and GATHER2, were multicenter, randomized, double-masked, and sham-controlled. Both trials enrolled patients with non-centerpoint involving GA, located within 1500 µm from the foveal center. In GATHER1, 286 patients were randomly assigned to receive monthly ACP injections of either 1 mg or 2 mg, or a sham treatment in two parts. In GATHER2, 447 patients were randomly assigned to receive monthly ACP injections of 2 mg or a sham treatment.
The primary endpoint for both trials was the mean rate of change in GA area over 12 months, analyzed using square root transformations. The results from GATHER1 revealed that ACP 2 mg demonstrated a significant reduction in the mean rate of GA area change compared to the sham group over the course of 12 months (0.110 mm; P = 0.0072). This significant difference between ACP and sham treatment persisted throughout the 18-month period.
Similarly, in GATHER2, ACP 2 mg also achieved the primary endpoint, displaying a significant reduction in the mean rate of GA growth over 12 months (0.056 mm/yr; P = 0.0064). Importantly, this reduction in GA growth rate was consistent across different analyses. The use of observed data also confirmed the efficacy of ACP 2 mg, showing a reduction of 0.376 mm²/yr (P = 0.0039) in GA growth compared to the sham group.
The most common ocular treatment-emergent adverse events (TEAEs) in both treatment groups in both studies were related to the injection procedure. The incidence of ocular TEAEs over 12 months was slightly higher in the ACP 2 mg group compared to the sham group in both GATHER1 (52.2% vs 34.5%) and GATHER2 (48.9% vs. 37.4%). However, the overall safety data for ACP treatment remained consistent and manageable.
Danzig C. Intravitreal Avacincaptad Pegol in Geographic Atrophy: Post-Hoc Analysis of Vision Loss From the GATHER Clinical Program. Presented at: ASRS 41st Annual Meeting.