0.19-mg Fluocinolone Acetonide Implant Safe, Effective for Non-Infectious Uveitis

Aina Moll-Udina, MD

Credit: Oftalmologia Sant Cugat

New 12-month data suggest the 0.19-mg fluocinolone acetonide implant is both safe and effective in most patients in the treatment of non-infectious uveitis, in a real-world setting.¹

Among a cohort of eyes with non-infectious uveitis in Spain, a significant number of treated eyes reached sustained functional and structural improvements from week 2 after implantation, without major safety concerns during the study.

“In the current study, we observed a rapid improvement in best-corrected visual acuity (BCVA), which reached significance (vs. baseline) 2 weeks post-implantation and remained relatively stable over the following 12 months,” wrote the investigative team, led by Aina Moll-Udina, MD, of the Facultat de Medicina at the University of Barcelona.

Most patients with non-infectious uveitis require long-term care to manage their condition, with macular edema a common complication of the disease. Knowledge of the pathophysiology of the disease has progressed slowly in recent years but is known to be dependent on various inflammatory pathways. As a result, targeting and controlling chronic inflammation is the basis for new treatment approaches, including corticosteroids, but there are varying success rates and heterogeneous adverse events involved in these approaches.²

In this prospective, 2-year study, Moll-Udina and colleagues assessed the effectiveness of the 0.19-mg implant in patients with non-infectious uveitis from November 2018 – November 2020 in a single referral uveitis unit in Spain.¹ Individuals ≥18 years old who had uveitis macular edema and ≥ 12 months of follow-up were included in the analysis. Exclusion criteria included infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring ≥2 medications.

Investigators assessed effectiveness at week 2, as well as months 1, 3, 6, and 12 using a multi-component outcome measure. They defined the fluocinolone acetonide as effective if all components met at every time point, or the implant failed for patients when any of the components did not meet at any time point.

A total of 26 eyes from 22 patients were included in the study, with 96% of eyes having uveitic macular edema. In the year prior to implantation, a mean of 2 dexamethasone or triamcinolone acetonide injections per eye was used in 62% of the eyes.

Over the course of the 12-month study, as revealed by the multicomponent endpoint, the fluocinolone acetonide was effective at every time point in 15 (57.7%) eyes. The implant reached peak effectiveness as early as 2 weeks after implantation.

Moreover, the analysis showed the mean BCVA was significantly improved compared to baseline at all time points (all comparisons P <.01), as was the mean central macular thickness (CMT; all comparisons P <.01).The greatest reduction in CMT was 72.2 µm between baseline and week 2, with a maximum reduction of 105 µm at month 6. Similar significant reductions were observed in mean macular volume at all time points (all comparisons P <.01).

The percentage of patients with a preserved ellipsoid layer was found to be significantly greater than baseline (50.0%) at all time points from week 2 (P < 0.05). Mean anterior chamber cells were reduced compared to baseline at all time points, with significance reached from month 6 to month 12 (P < 0.05). In addition, the mean vitreous haze score was significantly reduced versus baseline at all time points (p < 0.05).

The factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-fluocinolone acetonide implant, higher immunomodulatory therapy load at baseline, and a thicker retinal nerve fiber layer (RNFL) at baseline (all P < .05). The factors predicting failure were male gender, thinner baseline RNFL, and treatment ineffectiveness at 1 month (P <.05). Regarding safety, investigators found no significant increases in intraocular pressure at any time point.

Moll-Udina and colleagues noted the markers of inflammation gradually declined over time, supporting the benefit of the implant in controlling underlying inflammation in non-infectious uveitis. In addition, they cited a marked absence of inflammatory relapses up to month 12, suggesting the implant reduces non-infectious uveitis recurrence.

“According to our study, 0.19-mg fluocinolone acetonide implant may help clinicians to reduce the burden of treatment on patients,” investigators wrote.

References

1. Moll-Udina A, Hernanz I, Sainz-de-la-Maza M, et al. 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;43(11):4181-4195. doi:10.1007/s10792-023-02828-6
2. Adán A, Moll-Udina A, Alba-Linero C, et al. Recent progress in the treatment of uveitic macular edema. Expert Rev Ophthalmol. 2019 doi: 10.1080/17469899.2019.1644168