BACKGROUND AND AIMS: Sphingosine 1-phosphate receptor modulators have been associated with an increased risk of macular edema. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator. METHODS: We report the proportions and incidence rates (per 100 patient-years of exposure) of Macular edema and other ocular adverse events in the etrasimod clinical program, including patients with ulcerative colitis, Crohn's disease, eosinophilic esophagitis, alopecia areata, and atopic dermatitis. Ulcerative colitis data were analyzed in 2 cohorts: Placebo-controlled ulcerative colitis and All ulcerative colitis (comprising the Placebo-controlled ulcerative colitis cohort plus open-label extension studies). RESULTS: In the Placebo-controlled ulcerative colitis cohort, Macular edema was reported in 2 patients receiving etrasimod (0.3%
incidence rate: 0.70) and 1 receiving placebo (0.3%
incidence rate: 0.84). In the All ulcerative colitis cohort, 1 patient (0.1%
incidence rate: 0.13) receiving etrasimod reported 2 events of Cystoid macular edema. All events were nonserious, and 1 led to treatment discontinuation. No events of Macular edema were reported in other conditions. Nine and 4 patients receiving etrasimod reported Vision blurred and Visual impairment adverse events, respectively. All events were nonserious and most did not require any intervention. CONCLUSIONS: Macular edema and other ocular events were uncommon in patients treated with etrasimod across multiple conditions. Incidence of Macular edema was comparable with placebo. CLINICAL TRIALS.GOV IDENTIFIERS: NCT02447302
NCT03945188
NCT03996369
NCT02536404
NCT03950232
NCT04176588
NCT04173273
NCT04682639
NCT04556734
NCT04162769.