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Following the 2019 FDA approval of Dexamethasone ntraocular suspension 9%, multicenter retrospective data is being collected in order to assess the drug’s real-world performance when used for control of inflammation following cataract surgery.
A large-scale retrospective case study has been initiated to collect real-world data on dexamethasone intraocular suspension 9%. Up to 600 patients at approximately 40 study sites will be included. Data abstracted from medical records will include the following, as available for each case: patient characteristics (age, gender, ethnicity, history of diabetes or glaucoma, risk factors for postoperative inflammation); surgical details (type of surgery, IOL and viscoelastic used, complications); concomitant medications; details of dexamethasone delivery and diffusion; clinical outcomes (anterior chamber cell/flare, visual acuity, IOP, tolerability); and surgeon and patient satisfaction.
Data from 31 eyes treated with dexamethasone intraocular suspension 9% at the Eye Institute of West Florida will be presented. Among eyes with records at postoperative days 1, 8, 14, and 30, complete anterior chamber cell clearing was present in 45%, 90%, 90%, and 100%. Complete anterior chamber flare clearing was present on day 1 in 87% and in 100% for all subsequent timepoints. The product was well tolerated in all eyes at this site, with no reported adverse events, and all eyes achieved target visual acuity. Mean (SD) IOP was 17.6 (5.15), 15.3 (3.16), 17.0 (4.24), and 15.5 (3.50) mm Hg at days 1, 8, 14, and 30.
This subset of interim data from a larger retrospective study on dexamethasone intraocular suspension 9% reconfirms the strong, early-acting antiinflammatory efficacy and tolerability seen in phase 3 clinical studies.