Izervay

The approval was based on data from the randomized, double-masked, sham-controlled, multicenter phase 3 GATHER1 (ClinicalTrials.gov Identifier: NCT02686658) and GATHER2 (ClinicalTrials.gov Identifier: NCT04435366) trials, which evaluated the efficacy and safety of Izervay in patients 50 years of age and older (mean age, 77 years) with GA secondary to AMD. Patients were randomly assigned to receive either avacincaptad pegol via intravitreal injection once monthly or sham.

The primary endpoint for both trials was the mean rate of change in GA, as measured by fundus autofluorescence at baseline, month 6, and month 12. Results from both studies showed that treatment with avacincaptad pegol led to a statistically significant reduction in the rate of GA growth from baseline to month 12 compared with sham (0.10mm/year; P <.01 in GATHER1 and 0.05mm/year; P <.01 in GATHER 2 with square root transformed data). The treatment was found to slow disease progression as early as 6 months. The effects were consistent across all prespecified subgroups (eg, age, gender, baseline GA disc area).