Safety and effectiveness of the fluocinolone acetonide intravitreal implant (ILUVIEN): 3-year results from the European IRISS registry study

Abstract

BackgroundThe ILUVIEN Registry Safety Study was a multicentre, open-label, non-randomised, observational, phase 4 study designed to assess the safety and effectiveness of the fluocinolone acetonide (FAc) implant in all indications in real-world practices in Europe.MethodsThe study included data collected prospectively and retrospectively. Patients receiving FAc implants between 2013 and 2017 were included and monitored until the last patient reached ≥3 years of follow-up. Mean intraocular pressure (IOP) data over the course of the study, along with IOP events, use of IOP-lowering therapy, mean change in visual acuity (VA) and information on supplemental therapy use were analysed post-FAc implantation.ResultsSix hundred and ninety-five eyes from 556 patients, with a mean±SD follow-up of 1150.5±357.36 days, were treated with a FAc implant. 96.7% of eyes had chronic diabetic macular oedema (cDMO). IOP lowering was achieved in 34.5% of eyes using topical agents and 4.3% by surgery. Seventy-three eyes (64.6% of 113 phakic) required cataract surgery during follow-up. Mean VA increased from a baseline of 52.2 letters to 57.1 letters at month 36, with improvement observed up to month 48. Supplementary therapies were given in 43.7% of eyes. When classified by length of cDMO less than or greater than the median duration those with a shorter history experienced greater VA gains than those with a longer history.ConclusionThis study confirms the favourable, long-term benefit-to-risk profile of the FAc implant in eyes with cDMO, with an additional benefit in patients when this therapy is administered earlier.

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When

“…The clinical efficacy of the Iluvien intravitreal insert has been demonstrated by other RCTs and several real-life observational studies [ 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 ] and confirmed by systematic reviews, meta-analyses, and expert panels [ 142 , 143 , 144 ].…”

“…Iluvien has shown higher effectiveness in chronic (>3 years duration) DME eyes [ 40 ] and has provided both functional and anatomic improvements in DME eyes with persistent DME and refractory to previous therapies with laser, anti-VEGF, or other intravitreal steroids (TA or DEX) [ 133 , 135 , 137 , 138 , 140 , 144 , 145 , 146 ].…”

“…In real-world observational studies, the percentages of IOP-related side effects attributable to Iluvien appeared significantly lower than those reported by the FAME pivotal study [ 85 ]. Iluvien intravitreal implant was associated with a mean risk of post-operative IOP elevation of 20%, depending on the different definitions of IOP rise, with a risk of steroid-induced glaucoma of 0–10% [ 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 , 142 , 143 , 144 , 149 ] and a mean requirement of glaucoma surgeries of 0.6%, ranging from 0% to 4.3% [ 142 , 143 ], whereas a minority of cases should receive glaucoma surgery, including trabeculectomy, shunts implant, and minimally invasive glaucoma surgery [ 148 ].…”

“…Previous studies have shown that, although a single 3-year FAc implant was used in more than two-thirds of cases [ 40 , 142 , 143 ], additional treatments, such as laser photocoagulation, anti-VEGF, or intravitreal steroids achieving an acutely higher concentration, such as the TA or DEX implant, are required in the 33–75% of cases during the 3-year duration of the FAc implant [ 40 , 136 , 138 , 139 , 140 , 141 , 142 , 144 ]. On the other hand, when the FAc IV insert is considered as an additional therapy, it has been shown to significantly reduce the need for IV pharmacotherapy in DME eyes [ 85 , 134 , 141 ].…”

“…Presence of chronic DME: In cases of chronic edema, anti-VEGF has demonstrated poor efficacy [ 60 , 151 , 158 ], whereas IV CSs have shown efficacy in persistent DME unresponsive to anti-VEGF therapy [ 40 , 42 , 89 , 125 , 133 , 135 , 137 , 138 , 140 , 144 , 145 , 146 ].…”