Zimura for geographic atrophy continues to show positive results in second phase 3 trial
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The GATHER2 phase 3 clinical trial of Zimura for the treatment of geographic atrophy met its primary endpoint and demonstrated a favorable safety profile, according to a press release from Iveric Bio.
GATHER2, the second phase 3 trial of Zimura (avacincaptad pegol), enrolled 448 international participants who were randomly assigned to receive either an intravitreal injection of Zimura 2 mg or sham monthly for 12 months.
The prespecified primary endpoint of mean rate of growth (slope) in geographic atrophy (GA) area was met, with a 14.3% reduction over 12 months (P = .0064) using square root transformation and a 17.7% reduction (P = .0039) using observed GA area.
Additionally, a post hoc analysis of U.S. participants showed a 25.5% reduction (P = .0037) using square root transformation and a 32% reduction (P = .0033) using observed GA area. The mean baseline lesion size in U.S. participants was 13% smaller than patients outside the U.S. “The company’s preliminary hypothesis for regional variation is disease stage,” the release said. “The company previously hypothesized that Zimura may be more impactful in earlier stages of GA, based on post hoc analysis of the GATHER1 data. Consistent with this finding, patients in the U.S. in GATHER2 may have been recruited at an earlier stage of the disease as evidenced by the smaller baseline lesion size.”
There were no cases of endophthalmitis, intraocular inflammation or ischemic optic neuropathy through month 12, and the most frequently reported ocular adverse events were related to the injection procedure.
“The results from GATHER1 and GATHER2 and our special protocol assessment with the FDA provide the basis for [a new drug application], which we are planning to submit by the end of first quarter of 2023,” Glenn P. Sblendorio, CEO of Iveric Bio, said in the release.
A final evaluation of trial data will take place at 24 months.
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