Fluocinolone acetonide (FAc) intravitreal implant 0.19 mg (ILUVIEN®) is a nonbiodegradable, injectable, corticosteroid implant that is approved in several countries, including the USA, for the treatment of diabetic macular edema (DME). However still there is a risk of infection in most of the implants.
The team of researchers 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. The study published in journal International Opthalmology suggests that FAc implant is safe and a reliable option as chances of infection are less in non- infectious uveitis.
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.
The key findings of the study are
• A total of 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.
Researchers concluded that “The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
Reference: Moll-Udina A, Hernanz I, Sainz-de-la-Maza M, Pelegrín L, Coelho-Borges AI, Pazos M, Adán A, Llorenç V. Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months. Int Ophthalmol. 2023 Nov;43(11):4181-4195. doi: 10.1007/s10792-023-02828-6. Epub 2023 Sep 12.