Avacincaptad pegol slows geographic atrophy growth in phase 3 trial
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CHICAGO — Avacincaptad pegol helped slow the rate of geographic atrophy growth compared with sham treatment, according to a study presented at Eyecelerator@AAO.
Dhaval Desai, PharmD, senior vice president and chief development officer at Iveric Bio, presented results from the GATHER2 study of avacincaptad pegol, which is part of a larger phase 3 clinical program.
“The GATHER program consisted of two clinical trials that looked at avacincaptad vs. sham for the treatment of geographic atrophy,” he said.
GATHER2, a phase 3 randomized, sham-controlled trial, evaluated efficacy and safety in 448 patients randomly assigned to receive monthly avacincaptad pegol injections or sham treatment for 12 months. After the first year, patients in the treatment arm were randomly assigned again to receive either every month or every other month treatment for another 12 months.
The primary endpoint was rate of growth in geographic atrophy from baseline to month 12.
Desai said avacincaptad pegol achieved its primary endpoint and showed a 14.3% reduction in growth rate compared with sham (P = .0064). It also showed benefit across all of the study’s prespecified subgroups.
No cases of intraocular inflammation, endophthalmitis or ischemic optic neuropathy were reported in the treatment or sham arms.
In the treatment arm, 15 patients developed choroidal neovascularization compared with nine patients in the sham arm.
“GATHER2 met the prespecified primary endpoint with a high degree of statistical significance,” Desai said. “This is consistent with the findings of the GATHER1 study, with both curves showing an early separation and continuing to separate over time. Taken together, these results make avacincaptad pegol the first investigational therapy in GA to achieve the 12-month prespecified primary endpoint in two pivotal phase 3 studies.”
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Desai D. GATHER clinical program overview: Avacincaptad pegol in geographic atrophy. Presented at: Eyecelerator@AAO; Sept. 29, 2022; Chicago.
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