The 0.2-μg/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis

Objective: To examine the long-term efficacy and safety of the intravitreal 0.2-mu g/day fluocinolone acetonide implant (FAi) to treat noninfectious uveitis (NIU) of the posterior segment (PS).Design: Three-year, phase III, multicenter, randomized, double-masked, controlled, prospective study (clinicaltrials.gov, NCT02746991).Participants: Overall, 153 patients in India with NIU-PS in > 1 eye (with or without anterior uveitis) for > 1 year who had > 2 separate recurrences of uveitis requiring ocular injections or systemic therapy in the prior 12 months.Methods: Patients were randomized 2:1 for baseline FAi or sham injection and monitored for main outcome measures. Main Outcome Measures: Incidence and timing of uveitis recurrence, use of adjunctive therapy, best-corrected visual acuity, central foveal thickness, and monitoring of intraocular pressure (IOP)-and cataract-related events over 36 months.Results: Overall, 153 patients (FAi, n = 101; treated sham, n = 52) were enrolled. Fluocinolone acetonide implant-treated eyes had significantly reduced uveitis recurrence rates versus treated sham (46.5% vs. 75.0%, respectively; P = 0.001) and a longer median time to recurrence (1116.0 [95% confidence interval, 847.00 to not evaluable] vs. 190.5 [95% confidence interval, 100.0e395.0] days for treated sham). Systemic adjunctive treat-ments were similar between groups, but fewer FAi-treated eyes required adjunctive injections (8.9% vs. 51.9% for treated sham). Visual outcomes were similar between groups, and residual macular edema was more common at 36 months in treated sham versus FAi-treated eyes (46.2% vs. 24.2%, respectively). The FAi-treated group had a lower central foveal thickness from month 12 onward. Intraocular pressure-lowering surgeries were stable in both groups, but, as expected, rates of IOP elevations were more frequent in the FAi-treated group than in the treated sham (IOP > 25 mmHg: 23.8% vs. 3.8%; IOP > 30 mmHg: 16.8% vs. 1.9%, respectively), and FAi-treated eyes had a higher incidence of cataract surgery than the treated sham (70.5% vs. 26.5%, respectively).Conclusions: In patients with NIU-PS, the 0.2-mu g/day FAi is associated with reduced-uveitis recurrence and increased time to first recurrence while controlling macular edema, maintaining stable IOP levels, and providing an expected safety profile, including a higher occurrence of cataract formation over 36 months.

Automated summary

The study shows that the intravitreal 0.2-mu g/day fluocinolone acetonide implant is effective in reducing the recurrence rate of noninfectious uveitis and prolonging the time to first recurrence. In addition, it helps control macular edema and maintain stable intraocular pressure levels but increases the risk of cataract formation.