Details
Faricimab-svoa is a bispecific antibody currently approved for treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Faricimab-svoa was selected for this signal identification study based on high utilization and its status as a recently approved new molecular entity.
The U.S. Food and Drug Administration (FDA) initiated one analysis in Sentinel using a tree-based scan statistic to support this safety signal identification for faricimab-svoa. A self-controlled risk interval design with Tree-Only Scan and Tree-Temporal Scan methodologies were used to evaluate incident outcomes and temporal clusters of incident outcomes, respectively, among new users of faricimab-svoa.
The goals of the study were (1) to monitor non-pregnancy and non-cancer safety outcomes among new users of faricimab-svoa; (2) to identify any imbalances in safety outcomes after treatment initiation compared with a baseline time period before treatment initiation, and (3) evaluate how such safety outcomes are distributed in time after treatment initiation. Overall, the study did not identify any new safety concerns for faricimab-svoa in this sample of real-world patients.
Statistical alerts are triaged in consideration of study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3). After evaluating the statistical alerts generated by this study in the context of other information, the FDA did not identify any new safety concerns and determined that no further evaluation is warranted at this time.