For a study, researchers sought to evaluate the long-term safety and effectiveness of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien; Alimera Sciences, Inc) in diabetic macular edema patients (DME). Patients with DME who had previously received corticosteroid therapy but did not experience a clinically significant increase in intraocular pressure (IOP; all eyes, n = 202 eyes of 159 patients; 36-month completion, n = 94 eyes) were included. It was prospective, observational research in which participants were given a 0.19-mg FAc intravitreal implant at the start of the study and subsequently monitored for safety, visual, anatomic, and treatment burden results for up to 36 months. The primary safety outcomes were changes in IOP and treatments to control IOP rises. Changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and frequency of adjunctive DME therapy were secondary outcomes.
When compared to baseline, the subject eyes had a mean CST change of -60.69 μm (P=0.0001) and a mean BCVA change of +3.61 letters (P=0.0222) 36 months following FAc implantation. Overall, the median treatment frequency fell from 3.4 treatments per year in the 36 months before FAc implantation to 1 treatment per year in the 36 months following FAc implantation, representing a 70.5% reduction in treatment burden. Furthermore, 25.53% of eyes in the group that completed 36 months of therapy (n=94 eyes) remained rescue free after 36 months. Throughout the trial, mean IOP remained steady, while IOP rises of higher than 30 mmHg occurred in 10.89% of eyes. With a surgical rate of 2.97%, intraocular pressure-related operations were uncommon, with 1.49% linked to steroid usage (vs. surgeries attributable primarily to neovascular glaucoma). Furthermore, an IOP response of 25 mmHg following the steroid challenge suggested that 96.92% of eyes would have a similar result to the 0.19-mg FAc implant at the previous visit. The increases in intraocular pressure that did occur were controllable with routine therapy (n=202 eyes). In DME patients, the 0.19-mg FAc implant enhanced visual results and lowered treatment burden while retaining a positive safety profile.