Clinical Ophthalmology (Jun 2022)

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

  • Bacharach J,
  • McCabe C,
  • Jackson M,
  • Rao S,
  • Singh IP,
  • Heersink S,
  • Radcliffe N,
  • Weinstock R,
  • Paggiarino D,
  • Patel K

Journal volume & issue
Vol. Volume 16
pp. 1783 – 1794

Abstract

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Jason Bacharach,1 Cathleen McCabe,2 Mitchell Jackson,3 Sanjay Rao,4 I Paul Singh,5 Sebastian Heersink,6 Nathan Radcliffe,7 Robert Weinstock,8 Dario Paggiarino,9 Keyur Patel9 1North Bay Eye Associates Petaluma, Petaluma, CA, USA; 2The Eye Associates, Bradenton, FL, USA; 3Jacksoneye Ophthalmology, Lake Villa, IL, USA; 4DeKalb Eye Consultants - Hauser-Ross Eye Institute, Sycamore, IL, USA; 5The Eye Centers of Racine & Kenosha, Racine, WI, USA; 6Eye Center South, Dothan, AL, USA; 7New York Eye Surgery Center, Bronx, NY, USA; 8The Eye Institute of West Florida, Largo, FL, USA; 9EyePoint Pharmaceuticals, Watertown, MA, USACorrespondence: Jason Bacharach, North Bay Eye Associates, 104 Lynch Creek Way, Suite 15, Petaluma, CA, 94954, USA, Email [email protected]: 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.Keywords: cataract surgery, corticosteroids, dexamethasone, inflammation, intraocular suspension, ocular drug delivery systems

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