Real-World Data Suggest Safety, Efficacy of Fluocinolone Acetonide for NIU-PS

A recent systematic review has indicated the safety and efficacy of .19 mg fluocinolone acetonide sustained-release intravitreal implants for treating non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in real-world scenarios.1

The standard treatment method for NIU is corticosteroids; however, local and/or systemic side effects can constrain their use. Immunosuppressive agents have become an increasingly common method of managing ocular inflammation caused by NIU. Many of these treatments, however, come with the risk of adverse effects.2

Fluocinolone acetonide was initially approved in 2019 for the treatment of recurrent NIU-PS in Europe. Real world data have emerged since then to improve awareness of patient outcomes in everyday clinical practice.1

“With this systematic review of real-world studies, we aimed to review and discuss the current landscape of evidence and provide an overview of efficacy and safety outcomes of fluocinolone acetonide for the treatment of recurrent NIU-PS in daily practice,” wrote Louise Fischer Christensen, MD, department of ophthalmology, Aalborg University Hospital, and colleagues.1

The study collected data from 2 multi-center and 10 single-center studies, comprising a collective 514 eyes of 382 patients. All but one study included heterogeneous NIU etiologies with primary or secondary posterior segment involvement. Fluocinolone acetonide was generally used as a second- or third-line treatment following other local steroids. In 6 studies, all eyes had therefore received prior local steroid injections, with 2 studies requiring previous intravitreal 0.7 mg dexamethasone implantation for inclusion.1

Each of the reviewed studies reported sustained absence or improved intraocular inflammation levels following the fluocinolone acetonide implantation for up to 12 months. Effects on systemic therapy use varied; 7 studies reported lower oral steroid usage, while 1 study found an increase in the proportion of individuals requiring oral steroids and immunosuppressants. Another noted a decrease in the overall number of patients on systemic treatments; 2 more did not report any changes.1

Regarding safety outcomes, Christensen and colleagues noted mean IOPs remained stable across all studies except one, where a .8 mmHg mean increase from baseline at 6 months reached significance. Another study did not report mean IOP values but noted 2 eyes with increases ≥10 mmHg. Excluding these, the mean maximum IOP change was 3 mmHg.1

The need for supplemental medication post-implant ranged from 0% to 38.5% across 9 studies – 2 further studies noted increased in eyes requiring topical treatment, from 26.3% to 31.6% at 12 months in one, and from 32% to 49% at 24 months in the other. Another noted an increase in the mean number of topical medications from .5 to .88 at 12 months. No IOP-lowering surgeries were undertaken in 9 studies, but were needed in 4.1% (6 eyes), 8% (4 eyes), and 10% (2 eyes) in 3 other studies.1

While fluocinolone acetonide did exhibit a general potential to reduce or maintain systemic immunosuppressive treatments, the effect was not consistently observed, especially in cases involving choroidal inflammation. Local rescue treatment was used in 24% of eyes, and mean intraocular pressure remained stable for 36 months, with up to 38.5% of eyes requiring either supplemental or initial IOP-lowering medication. Additionally, implantation-associated ocular hypotony occurred in up to 9.1% of eyes with no sequelae noted. There was 1 case of retinal detachment reported and subsequently deemed unrelated to fluocinolone acetonide injection.1

Christensen and colleagues noted these data are corroborated by prior trial results, indicating the .19 mg fluocinolone acetonide intravitreal implant is an effective method of maintaining treatment for recurrent or chronic NIU-PS. The team also encourages further study to optimize its use.

“Regular IOP monitoring should allow for timely pressure-lowering treatments to be implemented,” Christensen and colleagues wrote. “Further studies are needed to determine the optimal placement of fluocinolone acetonide in the treatment algorithms for NIU-PS.”1

References

1. Christensen LF, Hassing AK, Klefter ON, Vorum H. Efficacy and Safety of Fluocinolone Acetonide 0.19 mg Intravitreal Implant for the Treatment of Non-Infectious Uveitis: A Systematic Review of Real-World Evidence. Ocul Immunol Inflamm. 2025;33(4):683-694. doi:10.1080/09273948.2024.2435472

2. Hornbeak DM, Thorne JE. Immunosuppressive therapy for eye diseases: Effectiveness, safety, side effects and their prevention. Taiwan J Ophthalmol. 2015;5(4):156-163. doi:10.1016/j.tjo.2015.03.004