The 0.19-mg Fluocinolone Acetonide Intravitreal Implant Reduces Treatment Burden in Diabetic Macular Edema.

Abstract

To assess treatment burden in patients with diabetic macular edema (DME) after the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN). Prospective and retrospective analyses of a 36-month, phase 4, open-label, observational study. Setting: Multicenter. Included patients had DME and previously received corticosteroid treatment without a clinically significant rise in intraocular pressure (IOP) (N = 202 eyes in 159 patients). Patients were not randomized. Prospective, observational treatment burden data were analyzed for their relationship to safety and functional efficacy outcomes across 36 months. Outcomes included the mean number of yearly treatments, supplemental-free probability over time, best-corrected visual acuity, and monitoring of IOP-related events. Over 36 months, the mean number of yearly treatments decreased from 3.5 before FAc to 1.7 after FAc; at 36 months, 68.3% of patients required 0 to 2 treatments per year. After FAc, the percentage of eyes requiring supplemental therapy decreased vs before FAc (P < .0001 for each). Through 36 months, 25% of FAc-treated eyes did not require supplemental treatment. At 36 months, mean best-corrected visual acuity increased by 4.5 letters vs a decline of 6.4 letters in the 36 months before FAc. IOP elevations >25 mm Hg occurred in 18.2% of eyes that did not receive supplemental treatment after FAc vs 27.2% of eyes that received supplemental treatments, which included additional intraocular steroids. Over 36 months, the FAc implant is associated with improved visual outcomes and better disease control as measured by a significant reduction in yearly treatment burden in patients with DME.