Real-world characteristics and safety outcomes of 10 000 eyes treated with intracanalicular dexamethasone insert: IRIS registry analysis 2019 to 2021.

PURPOSE

To characterize real-world patient profiles and safety-related diagnoses from the first 10 000 eyes receiving the dexamethasone intracanalicular (DEX) insert indicated for the treatment of ocular inflammation and pain after ophthalmic surgery.

SETTING

American Academy of Ophthalmology Intelligent Research in Sight Registry.

DESIGN

Retrospective cohort study of electronic health records.

METHODS

All eyes that received DEX 2 days before or up to 7 days after cataract surgery (DEX+ group) between June 1, 2019 (start of commercialization), and March 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

10 313 DEX+ and 425 098 DEX- eyes were analyzed 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%] vs n = 104 205 [24.5%], P < .0001), and approximately one-quarter of eyes in both cohorts had preexisting 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 < .0001) and epiphora (n = 73, 0.7% and n = 899, 0.2%, respectively, P < .0001) was low. DEX+ and DEX- cohorts had comparable incidence of intraocular pressure (IOP) elevations ≥10 mm Hg and similar mean IOP changes through postoperative month 1.

CONCLUSIONS

The DEX insert was found to have comparable inflammation, lacrimal disorder, and IOP outcomes with 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.