ILUVIEN® (190 micrograms fluocinolone acetonide) real-life safety and effectiveness following usage in three European countries – results from the 2016 extract of data from the ILUVIEN Registry Safety Study (IRISS)

Session Details

Session Title: Free Paper Session 2: Vascular Diseases & Diabetic Retinopathy I

Session Date/Time: Thursday 07/09/2017 | 09:00-10:30

Paper Time: 09:18

Venue: Room 117

First Author: : U.Chakravarthy UK

Co Author(s): :    S. Taylor   C. Bailey   F. Koch   J. Souza                    

Abstract Details


ILUVIEN is indicated for the treatment of chronic macular edema (DME) based on evidence from the pivotal FAME trials when laser was a first-line therapy. Today anti-VEGF is the most common first line standard of care for patients with chronic DME, but up to 50% of patients may have a sub-optimal response. The IRISS Study is designed to assess the safety (intra-ocular pressure) and efficacy (visual acuity) of ILUVIEN used in patients who have had a sub-optimal response in real world clinical practice


Interim analysis of an open label, observational registry study being conducted in the United Kingdom, Germany and Portugal to monitor the safety of the FAc implant for up to 5 years.


Data from 628 eyes from 531 patients (69 phakic eyes) were entered into IRISS from 31 centres in the UK, 11 in Germany and 5 in Portugal. Analysis was conducted on data collected up to 15th February 2017 with a follow-up period of 464.9 days (1-1269 days). Mean changes in IOP and VA were calculated


At the time of the data cut, 38 of 69 phakic eyes had cataract surgery. 23.3% of eyes treated with ILUVIEN required topical IOP-lowering drops and IOP-lowering surgery was performed in 1.7% of eyes. From a baseline VA of 51.9 ETDRS letters, VA improved by ≥5-letters in 46.4% of eyes at a follow up point of month 12 and 51.0% of eyes at month 24. VA remained within 4-letters of baseline in 28.6% and 22.4% of eyes at months 12 and 24, and worsened by ≥5-letters in 25.2% and 26.6% of eyes at months 12 and 24


These real-world data showed that fewer than one-in-four eyes required IOP-lowering topical medication with a very low rate of incisional IOP-lowering surgery at this interim time point. Visual improvements were sustained throughout the study period with the majority of eyes experiencing sustained or improved VA.

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