GATHER 2: Avacincaptad pegol slows geographic atrophy growth
The investigational geographic atrophy (GA) therapy avacincaptad pegol effectively slowed the rate of GA growth in patients with the disease, according to data from the Phase 3 GATHER 2 trial.
This is the first time an investigation therapy in GA has achieved the 12-month prespecified, primary endpoint in phase 3 studies.
During a presentation of the data at AAO 2022, Arshad M Khanani MD told attendees that avacincaptas pegol is a pegylated RNA aptamer designed to be a specific inhibitor of complement C5, which may slow inflammation and cell death associated with the development and progression of GA.
In the randomized phase 3 trial, 448 patients with GA with a non-center point involving GA lesion and GA in a part within 1500 um from the foveal center, were randomized the received treatment with monthly avacincaptas pegol (n = 225) or sham (n = 222). Baseline characteristics, including ocular characteristics, were well-balanced between groups.
In both groups, treatment fidelity through the first year was >90%.
The prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months was met with a high degree of statistical significance.
There was a 14.3% in mean rate of growth (Slope) in GA area and a 17.7% reduction in observed GA area in patients treated with avacincaptas pegol compared with patients treated with sham.
“We saw a separation of treatment effect early and that effect continued over time,” said Dr Khanani. “Both GATHER 1 and GATHER2 studies have shown us that we see a treatment effect early with AVA that increases over time. “
Khanani A, et al. GATHER2 Phase 3 Efficacy Results. Presented at AAO 2022.