Extended real-world experience with the ILUVIEN® (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft® audit study

Abstract

Background This study aimed to assess the long-term effectiveness of the 0.2 μg/day fluocinolone acetonide (FAc) implant over ≥3 years for patients with diabetic macular oedema. Methods A retrospective audit of pseudo-anonymised data from patients with chronic diabetic macular oedema (cDMO) and treated with the FAc implant across 14 UK clinical sites. Safety and clinical effectiveness were measured. Results Two-hundred and fifty-six eyes had ≥3 years of follow-up (mean 4.28 years), during which a mean of 1.14 FAc implants were used per eye. Mean best-recorded visual acuity (BRVA) increased from 52.6 to 56.7 letters at month 3 and remained stable thereafter; this trend was also seen in pseudophakic eyes. The proportion of patients attaining a BRVA ≥6/12 increased from 17% at baseline to 27% 1 month after FAc implant and remained stable above 30% from month 12 onwards. Eyes with no prior history of intraocular pressure (IOP)-related events required significantly less treatment-emergent IOP-lowering medication than those with a prior history of IOP events (17.9% vs. 50.0% of eyes; p < 0.001). The incidence of an IOP increase of ≥10 mmHg, use of IOP-lowering medication, laser trabeculoplasty and IOP-lowering surgery was 28.9%, 29.7%, 0.8% and 2.7%, respectively, for the whole cohort. There were significant reductions in mean central foveal thickness and macular volume (p < 0.001). Conclusions The FAc implant was well tolerated, with predictable and manageable IOP-related events while delivering a continuous microdose of corticosteroid to eyes with cDMO, providing prolonged vision preservation and a reduced number of treatments.

Intravitreal Corticosteroid Implantation in Diabetic Macular Edema: Updated European Consensus Guidance on Monitoring and Managing Intraocular Pressure

“…•Relative to eyes without a history of prior IOP events, eyes with a history of prior IOP events that received an intravitreal fluocinolone acetonide implant for DME had a significantly higher incidence of [ 19 ]:…”

“…Non-glaucomatous patients who may have higher than average susceptibility to a rise in IOP include those with higher IOP at baseline or a history of a prior rise in IOP (including a history of needing IOP-lowering treatment) [ 19 , 21 ]. It is logical that monitoring may need to be more frequent and/or extensive in these more susceptible patients and, as a result, we advise closer monitoring for patients with a: Baseline IOP of ≥ 22 mmHg (ocular hypertension according to the European Glaucoma Society [ 43 ]).…”

“…The 1-month check has been shown to have value in identifying an increased risk for subsequent ocular hypertension [ 24 ] but an increase in IOP can occur at any time during the life of the implant and not only in the weeks and months immediately following implantation. Indeed, with the fluocinolone acetonide implant, it has been reported that the first observation of an IOP > 25 mmHg occurred a mean (± SD) of 418 ± 324 days post-implantation [ 19 ]. This wide variability in possible timing underscores the need for regular monitoring throughout the lifespan of the implant.…”

“…Although it is not possible to determine prior to treatment which patients will experience an IOP rise, several risk factors have been identified. These include: prior ocular hypertension or glaucoma [ 14 – 17 ], especially glaucoma treated with dual or triple therapy [ 18 ]; a history of an IOP rise or a prior or current need for IOP-lowering treatment [ 19 – 21 ]; a relatively high baseline IOP [ 14 , 20 , 22 ]; myopia [ 23 ]; axial length [ 24 ]; type 1 diabetes [ 18 ]; age [ 18 , 24 ]; and Latino and South Asian ethnicity [ 25 ]. Furthermore, other factors such as implant positioning can also affect the risk post-implantation [ 26 ].…”

Intraocular Pressure Changes After Intravitreal Fluocinolone Acetonide Implant: Results from Four European Countries

“…Cataract is very common and appears on average 6–18 months after the injection [ 17 ]. IOP elevation occurs in 7–18% of patients [ 18 , 19 ], and in 15–37% of cases it may require treatment with IOP-lowering medication, laser trabeculoplasty or IOP-lowering surgery [ 18 , 20 – 22 ]…”