Real-world experience with 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom

Abstract

AimsTo compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2 μg/day fluocinolone acetonide (FAc).MethodsFourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30 mm Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications.ResultsIn total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30 mm Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30 mm Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5 μm.ConclusionsWhile overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.

Figure 1

Predictors, based on prior intraocular pressure (IOP)-related event (+) or no prior IOP-related event (-) for (a) emergent IOP-lowering medications and (b) IOP peak >30 mm Hg after 0.2 μg/day fluocinolone acetonide implant. Prior event is defined as report of IOP elevation, glaucoma, trabeculoplasty, glaucoma surgery, trabeculectomy, any IOP ≥21 mm Hg, IOP increase≥10 mm Hg, or report of any IOP-lowering medication.

Figure 2

Best-recorded visual acuity (BRVA) over time^a in all patients and pseudophakic patients alone (a) and vision distribution over time with 0.2 μg/day fluocinolone acetonide implant (b). ^aBaseline data were included, if there was a later data point for comparison. Data were excluded, if only baseline data or only follow-up data were available. BRVA, best-recorded visual activity; ETDRS, Early Treatment Diabetic Retinopathy Study; FU, follow-up; M, month.