Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN ® ) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months

Purpose: This assessed the effectiveness of the 0.19 mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain. Methods: A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes, with effectiveness defined as all components being met at every timepoint. Secondary outcome measures: onset or progression of glaucoma and investigator-reported adverse events. Results: Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p  < 0.01). During the 12-month study, markers of inflammation (anterior chamber cells and vitreous haze) also significantly declined. Factors predicting effectiveness at month 12: systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fiber layer (RNFL) at baseline (all p < 0.05). Factors predicting failure: male, thinner RNFL at baseline and treatment ineffective at 1 month (all p  < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increases in IOP. Conclusion: The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.