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

Abstract

PURPOSE:

This study 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. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were 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, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected.

CONCLUSION:

The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.

• Authors: Aina Moll-Udina, Inés Hernanz, Maite Sainz-de-la-Maza, Laura Pelegrín, Ana Isabel Coelho-Borges, Marta Pazos, Alfredo Adán, Victor Llorenç
• Journal: International ophthalmology (Int Ophthalmol) Vol. 43 Issue 11 Pg. 4181-4195 (Nov 2023) ISSN: 1573-2630 [Electronic] Netherlands
• PMID: 37698661 (Publication Type: Journal Article)
• Copyright: © 2023. The Author(s).

Chemical References

• Fluocinolone Acetonide

Topics

• Humans
• Male
• Female
• Fluocinolone Acetonide
• Diabetic Retinopathy
• Macular Edema
• Prospective Studies
• Uveitis (diagnosis, drug therapy)
• Eye Infections, Bacterial
• Glaucoma