Fluocinolone Acetonide Implant Improves Visual Acuity in Non-Infectious Uveitis

The 0.18 fluocinolone acetonide intravitreal implant (FAi) successfully improved visual acuity, reduced macular edema (ME), and attenuated choroidal thickening in patients with non-infectious uveitis (NIU)-associated ME during a 12-month retrospective study.¹

The first FAi received approval from the US Food and Drug Administration (FDA) in October of 2018 for the treatment of chronic non-infectious intermediate, posterior, or panuveitis with active inflammation. The implant is designed to release medication over 3 years; the drug is housed within a nonbioerodible material.²

“Given its long-acting efficacy and potentially favorable safety profile, the 0.18 mg FAi may represent an effective treatment for NIU-ME,” Cong Chen, from the First School of Clinical Medicine at Southern Medical University in Guangzhou, China, and colleagues wrote. “However, no studies have yet specifically evaluated its effectiveness and safety in this demographic.”¹

Chen and colleagues included a total of 39 patients (50 eyes) in the study, all of whom were diagnosed with NIU-ME and were given an intravitreal FAi at the department of ophthalmology at the General Hospital of Central Theater Command between January and September 2024. Patients were included if they were aged ≥18 years and had a diagnosis of NIU-ME confirmed by medical history, lab investigations, ophthalmoscopy, fundus fluorescein angiography (FFA), and optical coherence tomography (OCT), as well as data from ≥12 months of follow-up. Patients were excluded if they had infectious uveitis, epiretinal membrane or vitreomacular interface traction, or media opacities precluding adequate fundus visualization.¹

All 39 patients underwent a comprehensive evaluation, including intraocular pressure (IOP) measurement, best-corrected visual acuity (BCVA), color fundus photography, ophthalmoscopy, FFA, and OCT. All patients then received a 0.18 mg FAi implant and were followed for ≥12 months. The primary outcome was changes in BCVA, IOP, central macular thickness (CMT), and subfoveal choroidal thickness (SFCT) from baseline.¹

Investigators determined recurrence based on individualized assessments, including increased intraocular inflammation related to NIU-posterior segment (PS) activity, exacerbation of ME, worsening of visual acuity, and/or the need to intensify anti-inflammatory therapy.¹

Prior to FAi implantation, the mean disease duration was 62.7 +/- 57.7 months. Panuveitis was present in 31 eyes, while posterior uveitis was displayed in 19 eyes. Uveitis etiologies included idiopathic (n = 42), Vogt-Koyanagi-Harada syndrome (n = 6), and sympathetic ophthalmia (n = 2). At baseline, 40 eyes were pseudophakic.¹

The mean BCVA at baseline was 0.65 +/- 0.33 logMAR. Postoperatively, mean BCVA values were 0.53 +/- 0.31 at 1 month, 0.48 +/- 0.32 at 3 months, 0.49 +/- 0.32 at 6 months, and 0.48 +/- 0.31 at 12 months (all P <.001), displaying substantial improvement. Mean baseline IOP was 13.9 +/- 3.1 mmHg, while postoperative measurements were 15.5 +/- 3.8 mmHg at 1 month, 16.3 +/- 4 mmHg at 3 months, 18.2 +/- 6.6 mmHg at 6 months, and 17.4 +/- 5 mmHg at 12 months.¹

CMT and SFCT also showed significant reductions during the study, starting at a baseline of 333.4 +/- 108.6 µm and 310 +/- 98 µm and decreasing to 239.7 +/- 54.4 µm and 244.2 +/- 49.9 µm at 12 months, respectively (all P <.001). Recurrence was observed in 7 eyes during the 12-month follow-up, with a mean time to recurrence of 6.9 +/- 3.5 months. All 7 recurrent patients had a history of extensive prior treatment, including multiple intravitreal implants and biologics. After rescue therapy, no further recurrence was observed in any of the eyes.¹

“FAi represents an important long-acting, local treatment option for Chinese patients with chronic NIU,” Chen and colleagues wrote. “Its long-term efficacy and safety require further validation in larger studies with extended follow-up durations.”¹

References

1. Chen, C., Zhang, WJ., Ding, Q. et al. Clinical effectiveness of the 0.18 mg fluocinolone acetonide intravitreal implant for non-infectious uveitis-associated macular edema: a real-world study. BMC Ophthalmol (2026). https://doi.org/10.1186/s12886-026-04661-8

2. Lee KJ. FDA clears sustained-release implant for noninfectious uveitis. AAO. October 16, 2018. Accessed February 23, 2026. https://www.aao.org/education/headline/fda-clears-intravitreal-steroid-implant-noninfecti