The US Food and Drug Administration (FDA) has approved avacincaptad pegol (IZERVAY) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval, granted to Iveric Bio, represents the second indication for a drug to treat the progressive form of vision loss, following the approval of pegcetacoplan injection (SYFOVRE) in February. Unlike pegcetacoplan, avacincaptad pegol targets the complement 5 (C5) pathway.
The approval comes amidst increased scrutiny of complement inhibitors for GA patients, especially after pegcetacoplan developers reviewed the product's potentially associated risk of retinal vasculitis. Avacincaptad pegol's approval was supported by data from two phase 3 clinical trials, showing a significant reduction in the mean growth rate of GA area in patients at 12 months. The GATHER2 trial reported a mean 17.7% reduction in GA area growth over 12 months in patients receiving the intravitreal injection therapy, with no observed adverse events.
Dr. Arshad M. Khanani, a GATHER trial program investigator, highlighted the importance of this approval for the retina community and patients suffering from GA, emphasizing the drug's potential to slow GA progression by targeting the source of retinal cell death. Additionally, new post-hoc analysis data from GATHER1 presented at the American Society of Retina Specialists Annual Meeting showed that avacincaptad pegol was linked to reduced GA lesion growth across all distances from the foveal center point versus sham, with sustained benefits among treated patients.