Primary efficacy endpoint modified for Zimura trial in geographic atrophy secondary to AMD
Iveric bio received a special protocol assessment from the FDA for GATHER2, a pivotal clinical trial investigating Zimura in patients with geographic atrophy secondary to age-related macular degeneration, according to a press release.
The FDA recommended a modified primary efficacy endpoint for the phase 3 trial of Zimura (avacincaptad pegol), which Iveric accepted. The modification was “from the mean rate of change in GA area over 12 months measured by fundus autofluorescence (FAF) at three timepoints: baseline, month 6 and month 12, to the mean rate of growth (slope) estimated based on GA area measured by FAF in at least three timepoints: baseline, month 6 and month 12,” the release said.
Iveric submitted a revised clinical trial protocol and statistical analysis plan for GATHER2, integrating the revised efficacy endpoint and statistical analysis method, which the FDA accepted.
“The modification of the primary efficacy endpoint does not require collecting any new data but instead reflects a change in how the data are analyzed. We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura,” Pravin U. Dugel, MD, president of Iveric bio, said in the release.
Topline data for the trial, which is nearing enrollment completion, are expected in the second half of 2022.
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