Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program.

Abstract

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 two 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 two patients receiving etrasimod [0.3%; incidence rate: 0.70] and one receiving placebo [0.3%; incidence rate: 0.84]. In the All ulcerative colitis cohort, one patient [0.1%; incidence rate: 0.13] receiving etrasimod reported two events of Cystoid macular edema. All events were non-serious, and one led to treatment discontinuation. No events of Macular edema were reported in other conditions. Nine and four patients receiving etrasimod reported Vision blurred and Visual impairment adverse events, respectively. All events were non-serious 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.