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

Purpose:

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

Setting:

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.

Methods:

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

Results:

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

Conclusions:

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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