First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

Abstract

Purpose To evaluate dexamethasone intraocular suspension 9% (intraocular DXM) in real-world clinical use to manage inflammation associated with cataract surgery. Setting Patients who underwent cataract surgery and received intraocular DXM at 22 outpatient eye surgery centers in the US. Design Retrospective, observational chart review. Methods Records of all patients who received intraocular DXM from March to December 2019 at participating centers were reviewed. Main Outcome Measures Outcomes included anterior chamber cell (ACC) grades, anterior chamber flare (ACF) grades, and visual acuity, as well as intraocular pressure (IOP) and adverse events (AEs) at postoperative days (PODs) 1, 8, 14, 30. Descriptive statistics were generated. Results The study population included 527 patients (641 eyes), with glaucoma history in 66 patients (80 eyes). Among eyes with recorded ACC grades, the percentage with grade 0 increased from 40% at POD 1 to 89.7% at POD 30, with similar results in eyes with glaucoma history. Among eyes with recorded ACF grades, the percentage with grade 0 increased from 78.4% at POD 1 to 97.1% at POD 30. At POD 30, 96.6% eyes with recorded results achieved target acuity. Mean IOP was 18.6 mmHg at POD 1 but declined to ≤15.2 mmHg thereafter. Investigators reported 22 AEs in 20 patients, all reported mild or moderate, the most common: IOP increase (7 events). Conclusion Patients undergoing cataract surgery and treated with intraocular DXM showed favorable inflammatory and visual outcomes, without unanticipated safety problems, consistent with results of previous controlled clinical trials.

Management of inflammation after the cataract surgery

“…Matossian and others [104 ▪▪ ] in their randomized clinical study showed that dexamethasone intraocular suspension was as effective as topical prednisolone drops and the rise of IOP was comparable between the groups. A recent study by Bacharach et al was the first real-world multicentre postmarketing study, in which results were similar to previous clinical trials: dexamethasone intraocular suspension was effective in inflammation control, adverse reactions were rare and mostly mild-to-moderate from which the most common was raised IOP (7 reported events from 527 patients), which showed that suspension is effective and well tolerated [105 ▪ ].…”

0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects

“…3 These findings are in alignment with a real-world observational study on the dexamethasone intraocular suspension 9%, where an ACC grade of 0 was achieved by 49/71 patients (69%) at Day 8 and 30/32 patients (93.7%) at Day 14 for patients who received intraocular dexamethasone only. 59 Lee et al evaluated a different formulation of dexamethasone (an intracanalicular plug) and found more patients with complete ACC clearance at Day 8 (22.4%) and at Day 14 (42.7%) than placebo; 60 our study had a much higher percentage at Day 8 (33.3%) and at Day 15 (66.7%). Pain scores fared similarly: at Day 8, 79.2% and at Day 14, 80.6% were pain free with the insert 60 (in our study, 82.1% at Day 8 and 89.7% at Day 15 were pain-free).…”

“… 3 These findings are in alignment with a real-world observational study on the dexamethasone intraocular suspension 9%, where an ACC grade of 0 was achieved by 49/71 patients (69%) at Day 8 and 30/32 patients (93.7%) at Day 14 for patients who received intraocular dexamethasone only. 59 …”