Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study

PURPOSE To evaluate the efficacy and safety of sustained-delivery fluocinolone acetonide (FAc) intravitreal implant for diabetic macular edema (DME). PATIENTS AND METHODS Prospective study in patients with DME insufficiently responsive to laser and anti-vascular endothelial growth factor (anti-VEGF). Patients with history of rise of intraocular pressure after intravitreal corticosteroids were excluded. RESULTS The macular edema rapidly decreased both in group 1 (prior laser only; n=7 eyes) and group 2 (prior laser and ≥3 monthly anti-VEGF therapy; n=10 eyes) and central subfield thickness was reduced by -299 μm (P=0.008) and -251 μm (P=0.016) at 12 months, respectively. Mean area under the curve from baseline to last value for pseudophakic eyes was +4.2 letters in group 1 and +9.5 letters in group 2. Overall, the FAc implant was well tolerated. CONCLUSION This prospective study confirms the efficacy of the FAc implant in DME patients insufficiently responsive to laser and anti-VEGF. Moreover, with a careful patient selection, our safety results would support an earlier use of FAc in the DME treatment pathway.