United Kingdom multicenter Medisoft™ electronic medical record real-world audit following implant of ILUVIEN^® (fluocinolone acetonide 190 µg) – the first 3-year results from the UK

Abstract

Purpose : ILUVIEN releases 0.2 µg of fluocinolone acetonide (FAc) as a continuous microdose for 36 months. In Europe it is indicated for use in patients with chronic diabetic macular edema (DME) that are responding suboptimally to available therapies (primarily intravitreal injections of anti-VEGFs). Since its approval there has been growing usage in UK clinical practices and the current extract assesses its long-term safety and effectiveness.

Methods : The Medisoft audit tool was used to search electronic medical records (EMR) across 14 UK sites to identify DME patients treated with ILUVIEN with a full 3 years of follow up. Data was extracted from 40 chronic DME patients (42 eyes). The majority of eyes were pseudophakic prior to ILUVIEN (n=39/42) or had a combined cataract operation on the same day as ILUVIEN was administered (n=1/42). Safety was assessed in terms of the occurrence of intra-ocular pressure (IOP) events and their management. Effectiveness was determined from changes in best-recorded visual acuity (BRVA).

Results : The time since first episode of DME was 3.79±0.43 years. The most widely used prior DME therapy was the intravitreal injection of anti-VEGFs (n=35/42). Prior to ILUVIEN the number of DME treatments per month was 0.24±0.31 and this was halved (0.12±0.02) after ILUVIEN was administered (P=0.005). By year three, 19.0% (n=8/42) of patient eyes experienced a rise in IOP above 30 mmHg and 23.8% (n=8/42) of these eyes required IOP-lowering drops to manage treatment-emergent IOP. None of the treated eyes received trabeculoplasty (n=0/42) or incisional IOP-lowering surgery (n=0/42). The proportion of eyes with 20/40 vision (70 ETDRS letters) had increased from 17% (n=7/42) at baseline to 31% (n=13/42) at year three. Stable / improved vision (≥-4 letters) was achieved in 79% (n=33/42) of eyes and 26.2% (n=11/42) of eyes gained ≥15 letters in BRVA.

Conclusions : The administration of the FAc implant led to a significant reduction in the number of DME treatments. There was a rise in IOP in 1 out of 4 patient eyes, which was manageable with topical medication. Over the three years, BRVA stabilised or improved in 4 out of 5 patient eyes. These data compare favourably with the outcomes in patients with chronic DME in the FAME trials at 3 years (see Table).

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.