Iveric Bio announces positive topline data for avacincaptad for GA
Iveric bio, Inc announced positive topline results from GATHER2, a phase 3 clinical trial of avacincaptad pegol (Zimura) for the treatment of geographic atrophy (GA).
Avacincaptad is a novel investigational complement C5 inhibitor.
GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a favorable safety profile.
Through month 12 of the trial, there were no events of endophthalmitis, no intraocular inflammation events, and no ischemic optic neuropathy events; 6.7% in the 2 mg treatment group and 4.1% in the sham group had choroidal neovascularization (CNV) in the study eye.
“We are thrilled to see for the first time an investigational therapy with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials,” stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “The results from GATHER1 and GATHER2 and our Special Protocol Assessment with the FDA provide the basis for an NDA, which we are planning to submit by the end of first quarter of 2023. We look forward to engaging with the FDA throughout the review process. I want to thank the many patients, physicians and their staffs for their participation in the Zimura clinical program along with the employees of Iveric Bio for their dedication to achieve this important milestone.”
Read the full press release here.