A post-hoc analysis of the GATHER1 trial suggests avacincaptad pegol reduced GA lesion growth across all distances from the foveal center point, when compared to sham.
New findings from a post-hoc analysis of the GATHER1 clinical trial suggest avacincaptad pegol (ZImura) showed a reduction of geographic atrophy (GA) lesion growth across all distances from the foveal center point compared to sham.
Data show approximately 84% of patients had lesions within 500 microns of the foveal center point at baseline and approximately 28% of patients had lesions within 100 microns of the foveal center point at baseline.
The report noted that the findings were generally balanced across treatment arms and the corresponding sham control groups within the trial. Additionally, the most frequently reported ocular adverse events were related to the injection procedure and there were no drug-related adverse events reported in GATHER1.
The findings were presented at the American Society of Retina Specialists 40th Annual Scientific Meeting.
In an interview with HCPLive, David Lally, MD, New England Retina Consultants, discussed the reasoning and methodology behind the post-hoc analysis and how the team investigated if the effect of avacincaptad pegol has any relationship to lesion locality at baseline.
“To answer this question, we wanted to determine the minimum distance from the foveal center point of the fovea to the edge of the lesion in these subjects and see if there was any difference in the effect of avacincaptad pegol, depending on the differences in the minimum distances from the foveal center point at baseline,” Lally said.
Images from the GATHER1 were collected and overlaid to determine the foveal center point and using autofluorescence, investigators measured the distance to the edge of the GA lesion at baseline.
Lally highlighted findings on the effect of the treatment of avacincaptad pegol depending on the minimum distance from the foveal center at baseline.
“What we saw is that as the minimum distance from the foveal center increases at baseline, we saw that the effect from avacincaptad pegol treatment was greater and it was a linear relationship that we could see over time,” Lally said.
He noted that since the enrollment criteria had to be within 1500 microns, it was considered the maximum minimum distance in the post-hoc analysis. In those patients, investigators saw a 50% reduction in growth at month 18, Lally said.
“I think this is exciting new data and developments that not only do we know that natural history can be dependent on lesion focality, but also the effects of our treatment can be different depending on the baseline lesion focality,” he added.
Previously, avacincaptad pegol met the primary efficacy endpoint with statistical significance in GATHER1. A second phase 3 clinical trial for avacincaptad pegol for GA, GATHER2, is expected to share topline data in the third quarter of 2022.