Abstract

Diabetic macular oedema (DMO) is a complication of diabetic retinopathy and a leading cause of visual impairment in patients with diabetes. ILUVIEN® (Alimera Sciences Inc., Alpharetta, GA, USA) is an intravitreal implant of fluocinolone acetonide (FAc), which is indicated in Europe for the treatment of vision impairment associated with chronic DMO that is considered insufficiently responsive to available therapies. This article reviews the clinical effectiveness and safety of the FAc implant from real-world studies presented at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting. Review findings: Evidence from real-world studies, with the FAc implant in persistent or recurrent DMO, show consistent outcomes at a similar time point with those reported in the pivotal randomised controlled trials (RCTs). Real-world studies have also shown that the FAc implant led to improvements in visual acuity and central retinal thickness, as well as reductions in treatment burden. Increases in intraocular pressure (IOP) observed in these studies were consistent with those reported at a similar time point in the RCTs and with the effect of other corticosteroid treatments. Expert opinion and conclusions: The results suggest that FAc offers a clinical and cost-effective alternative in the treatment of persistent or recurrent DMO. There are low risks of raised IOP and cataract formation, both of which are amenable to treatment.

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