The use of fluocinolone acetonide improves visual outcomes and disease control in patients with diabetic macular edema (DME), as measured by a significant reduction in annual treatment burden, according to a study.
Researchers used data from a 36-month, phase IV, open-label, observational study that included 159 DME patients who had been treated with corticosteroid without a clinically significant rise in intraocular pressure (IOP; n=202 eyes). All patients received the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant.
Endpoints included the mean number of yearly treatments, supplemental therapy-free probability over time, best-corrected visual acuity (BCVA), and IOP-related events.
Over 36 months, the mean number of yearly treatments dropped from 3.5 pre-FAc to 1.7 post-FAc. More than half of the patients (68.3 percent) required 0–2 treatments per year.
FAc also led to a significant decrease in the number of eyes requiring supplemental therapy (p<0.0001). Over 36 months, 25 percent of FAc-treated eyes did not require supplemental treatment.
Furthermore, mean BCVA increased by 4.5 letters at 36 months post-FAc as compared with a decline of 6.4 letters in the 36 months prior to FAc. IOP elevations of >25 mm Hg occurred in 18.2 percent of eyes that did not receive supplemental treatment post-FAc vs 27.2 percent of eyes that received supplemental treatments, which included additional intraocular steroids.