Real-World Characteristics and Safety Outcomes of 10,000 Eyes Treated with Intracanalicular Dexamethasone Insert: An IRIS® Registry Analysis 2019-2021

Purpose: To characterize real-world patient profiles and safety-related diagnoses from the first 10,000 eyes receiving the dexamethasone intracanalicular insert indicated for the treatment of ocular inflammation and pain following ophthalmic surgery (DEX). Setting: American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight) Design: Retrospective cohort study of electronic health records Methods: All eyes that received DEX two days before or up to seven days after cataract surgery (DEX+ group) between 6/1/2019 (start of commercialization) and 3/31/2021 were identified by procedure coding. A control cohort of eyes not receiving DEX (DEX- group) was drawn from the same practices as DEX+ eyes. Outcomes included characterization of demographics, comorbidities, and safety events of interest. Results: Overall, 10,313 DEX+ and 425,098 DEX- eyes were analyzed out of 3,703,177 eyes undergoing cataract procedures during the index period. Eyes with a history of coded conditions relating to ocular surface disease (OSD) received DEX at a higher rate than eyes without a history of OSD (n=3311 [32.1%] versus n=104,205 [24.5%], p<0.0001), and approximately one-quarter of eyes in both cohorts had pre-existing glaucoma (n=2634 and n=105,700 eyes, respectively). Postoperative inflammatory events, corneal edema, and lacrimal disorders were uncommon (<2%) and had a comparable incidence in both cohorts. In DEX+ and DEX- eyes, the incidence of cystoid macular edema (n=130, 1.3% and n=2673, 0.6%, respectively, p<0.0001) and epiphora (n=73, 0.7% and n=899, 0.2%, respectively, p<0.0001) were low. DEX+ and DEX- cohorts had comparable incidence of intraocular pressure elevations ≥10 mmHg and similar mean IOP changes through postop month 1. Conclusions: The DEX insert was found to have comparable inflammation, lacrimal disorder, and IOP outcomes to alternate perioperative therapy after cataract surgery, and real-world safety outcomes in this cohort of more than 10,000 eyes were similar to those observed in prior DEX clinical trials. The DEX intracanalicular insert may be considered as a suitable alternative treatment option to topical anti-inflammatory drops in patients undergoing cataract surgery.