Frontiers in pharmacology
Ocular safety signals of sphingosine-1-phosphate receptor modulators in postmarketing surveillance
By Fu M, Wang J, He Q and 4 others.
Abstract
Background
Sphingosine-1-phosphate (S1P) receptor modulators are used for immune-mediated diseases, and macular oedema is an established ocular adverse effect. However, ocular-focused, class-wide postmarketing reporting across all five approved agents remains incompletely characterized.
Methods
We analyzed U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) data from 2004 Q1 through 2026 Q1 using report-level deduplication, approval-aligned windows, and primary-suspect exposure. Ocular events were assessed using a curated set of 52 Preferred Term (PT) strings. Sensitivity analyses included report-level macular/retinal oedema aggregation, same-indication active comparators, temporal and sparse-data analyses, restricted empirical-Bayes assessment, and external validation in Canada Vigilance. Exact-date time to onset was assessed for the aggregated phenotype.
