The 0.2-μg/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India.

Objective: To examine the long-term efficacy and safety of the intravitreal 0.2-μg/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; Conclusions: In patients with NIU-PS, the 0.2-μg/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. Financial Disclosures: The authors have no proprietary or commercial interest in any materials discussed in this article.