Case Series Investigating the Efficacy and Safety of Bilateral Fluocinolone Acetonide (ILUVIEN(®)) in Patients with Diabetic Macular Edema

INTRODUCTION: Patients with diabetic macular edema (DME), a chronic, vision-limiting condition, may be insufficiently responsive to standard-of-care anti-vascular endothelial growth factor (VEGF) and/or laser therapies. One approved treatment for such patients is 0.2 μg/day fluocinolone acetonide (FAc) sustained-release implant; however, data are limited for treatment strategies in patients with bilateral chronic DME insufficiently responsive to standard-of-care therapies. METHODS: Six pseudophakic patients with bilateral, chronic DME previously treated with laser and anti-VEGF therapy (and intravitreal triamcinolone acetonide in 10 eyes) were retrospectively investigated for visual and anatomical outcomes, 6 months post-0.2 μg/day FAc implant in both eyes. RESULTS: At baseline, the mean best corrected visual acuity (BCVA) was approximately 6/38 or 43 [standard deviation (SD) ±17.4] Early Treatment Diabetic Retinopathy Study (ETDRS) letters; mean central retinal thickness (CRT) was 648 μm (SD ±160). Mean change in BCVA was +10 letters (SD ±12.2 letters), with 4/12 eyes maintaining or achieving driving vision (≥70 letters) and 3/12 eyes having unchanged BCVA. CRT was reduced 6 months after 0.2 μg/day FAc implant in 11/12 eyes. The mean intraocular pressure (IOP) was 16.1 mmHg [mean change of 1.1 mmHg (SD ±3.6)]. CONCLUSION: In a real-world setting, 0.2 μg/day FAc implant in both eyes was a feasible, effective choice for patients with severe bilateral DME, without notable increases in IOP. FUNDING: Publication charges were funded by Alimera Sciences Ltd. Medical writing assistance for this study was provided by QXV Communications and funded by Alimera Sciences Ltd. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40123-016-0045-7) contains supplementary material, which is available to authorized users.