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

Abstract

Purpose :
To report the final study results from the IRISS study with a focus on outcomes in patients with diabetic macular edema (DME).

Methods :
The IRISS study is a European 5-year post-authorisation registry study conducted in a total of a total of 556 patients (N=695 eyes) and studied for up to five-and-a-half years after being treated with the fluocinolone acetonide (ILUVIEN) implant.

Safety assessments included the occurrence of intra-ocular pressure (IOP) events and their management, and effectiveness included changes in best-recorded visual acuity (VA) with a focus on outcomes based on median duration of DME.

Results :
From the 695 eyes that were included, the majority (96.7%) had diabetic macular edema (DME) and had a mean follow-up of 37.8 months (up to a maximum of 65.0 months).

The focus here is therefore on the IOP outcomes and changes in VA reported in the DME population.

In patients with DME, 35.1% of eyes required IOP-lowering medication with a mean of 13.3±11.6 months (mean±SD) to the first IOP-lowering medication.

5.5% of eyes required IOP-lowering procedures (4.3% surgery and 1.2% non-penetrating) were required to control pressure with a mean of 25.9±10.6 months to the first procedure (surgery or non-penetrating).

A rise in pressure of ≥10 mm Hg and of >30 mm Hg was observed in 15.3% and 14.7% eyes, respectively.

Mean VA increased from a baseline of 52.3 letters to 57.5 letters at Month 36, with consistent improvements observed between months 12 and 36.

Subgroup analysis, based on median DME duration, showed improved VA changes in patients where the median duration was less than the median.

Conclusions : This study confirms the favourable long-term benefit-to-risk profile of the fluocinolone acetonide implant with additional benefits observed in patients with DME that were treated earlier.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.