Fluocinolone acetonide insert prevents recurrences in noninfectious uveitis

Treatment with fluocinolone acetonide insert (FAI) results in significantly reduced uveitis recurrence rates, increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and acceptable side-effect profile compared with sham, according to a study.

“These data support the FAI as an office-based rather than a surgical procedure that provides a useful long-term treatment option for noninfectious uveitis of the posterior segment (NIU-PS),” the researchers said.

This phase III, prospective, double-masked, multicentre study randomly assigned 129 patients (aged ≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids to either FAI 0.2 μg/day (n=87) or sham (injection plus standard or care; n=42) treatment.

FAI-treated compared with sham-treated eyes had significantly reduced cumulative uveitis recurrences (65.5 percent vs 97.6 percent; p<0.001), commensurately longer time to first recurrence (median, 657.0 vs 70.5 days; p<0.001), and significantly lower number of recurrences per eye (mean, 1.7 vs 5.3; p<0.001) over 36 months. [Ophthalmology 2020;127:1395-1404]

Compared with sham, FAI led to a ≥15-letter increase in best-corrected visual acuity (BCVA; 33.3 percent vs 14.7 percent) from baseline and fewer investigator-determined macular oedema (13.0 percent vs 27.3 percent) at month 36. Adjunctive treatments were also fewer among participants in the FAI vs sham group (57.5 percent vs 97.6 percent).

In addition, both study groups showed similar intraocular pressure (IOP) at month 36 (mean, 14.5±5.1 vs 14.8±5.3), and nearly half as many eyes in the FAI- vs sham-treated group underwent IOP-lowering surgery (5.7 percent vs 11.9 percent). Over 36 months, however, cataract surgery was required more frequently in the FAI-treated compared with the sham-treated group (73.8 percent vs 23.8 percent).

“These long-term results confirm and extend the month 6, 12, and 24 results that were reported previously and demonstrate that uveitis recurrence rates were significantly reduced compared with sham-treated eyes over the entire 36 months of this study,” the researchers said. [Ophthalmology 2016;123:1940-1948; Ophthalmology 2019;126:601-610; Graefes Arch Clin Exp Ophthalmol 2020;258:1023-1030]

Of note, the lower rate of IOP-lowering surgery in the FAI-treated group contradicted those from previous studies of the surgically implanted Retisert, which resulted in a higher IOP surgery rate compared with the dexamethasone implant. [Ophthalmology 2006;113:1020-1027; J Ocul Pharmacol Ther 2013;29:501-507]

The current study had certain limitations, such as the lack of data on specific types of intermediate, posterior, and panuveitis, which rendered the relative efficacy for specific uveitis diagnoses unclear. It was also underpowered to detect significant efficacy differences based on underlying uveitis aetiology.

“An important limitation of the long-term results reported is that the study was originally designed and powered to investigate differences in uveitis recurrence at 6 months; consequently, the current statistical comparisons are all powered from secondary objectives,” the researchers said.

“It is also important to recognize the high number of imputed recurrences, which could confound the results reported here; however, the clear separation in observed recurrences supports a benefit for FAI treatment,” they added.