0.18 Mg Fluocinolone Acetonide Implant, Corticosteroid Burst Useful Adjuvant for Uveitis

Timothy Janetos, MD, MBA

Credit: Northwestern Medicine

A corticosteroid burst followed by a 0.18 mg fluocinolone acetonide intravitreal implant (FAi) showed a moderate duration of inflammation control, with few complications related to intraocular pressure (IOP) among eyes with noninfectious uveitis.¹

However, results from the retrospective analysis showed no patients were weaned off systemic therapy during the study period, suggesting the 0.18 mg FAi is a useful adjuvant therapeutic option, but not sufficient as a primary therapy.

“Approximately 37.5% of eyes in our data were on systemic treatment to start and none were weaned off therapy, suggesting that the lower dosage of the 0.18 mg FAi may not be sufficient for solo treatment of intraocular inflammation in many cases,” wrote the investigative team, led by Timothy. M. Janetos, MD, MBA, the department of ophthalmology at Northwestern University Feinberg School of Medicine. “However, no patient on systemic therapy at the start of the study was weaned off therapy and there were many early failures, suggesting that the 0.18 mg FAi may be a useful adjuvant, but not sufficient as primary therapy.”

Currently, the US Food and Drug Administration (FDA) has approved three corticosteroid implants for the treatment of noninfectious posterior uveitis: the sutured 0.59 mg FAi, the 0.7 mg dexamethasone intravitreal implant, and the 0.18 mg FAi.² The 0.18 FAi is designed to last up to 36 months, longer than the 0.7 mg dexamethasone implant, and has the potential for fewer adverse events than the 0.59 mg FAi, given its lower dose.

Janetos and colleagues suggested a prior short-term corticosteroid burst, followed by the 0.18 mg FAI, could be beneficial, given the implant’s low dose, and help patients achieve longer-term inflammation control.¹ The team retrospectively reviewed long-term outcomes of 0.18 mg FAi with pre-injection corticosteroid burst at their institution. All patients with noninfectious uveitis who underwent implantation with the 0.18 mg FAi with pre-injection local corticosteroid burst and had ≥6 months of follow-up were in the analysis.

The analysis obtained participants’ demographic information and pre-injection baseline data from the planned corticosteroid burst visit immediately before the 0.18 mg FAi injection. Evaluated using Kaplan-Meier analysis, the primary analysis outcome was time to treatment escalation post-0.18-mg FAi, defined as any worsening inflammation requiring escalation. Janetos and colleagues indicated this was selected to clinically reflect the time to treatment failure.

Overall, the analysis included 32 eyes from 23 patients, with a mean follow-up time post-FAi of 19.8 months. Most patients were female (65.6%) and White (65.6%), and many patients (39.1%) were already on systemic therapy before the 0.18 mg FAi implantation. The local corticosteroid burst before 0.18 mg FAi implantation in most cases was the 0.7 mg dexamethasone implant (90.6% of eyes).

A corticosteroid burst was performed on an average of 2.4 months before the 0.18 mg FAi implantation. Cystoid macular edema (CME) was the primary indication for treatment, being present in 53.1% of eyes before the 0.18 mg FAi implantation. Overall, Kaplan-Meier analysis showed the mean time until treatment escalation was 20.3 months post-0.18 mg FAI (95% CI, 14.8 - 25.7 months).

Further analyses showed CME was present in 53.1% of eyes (n = 17 of 32) before the corticosteroid burst and decreased significantly (P <.001) to 18.8% (n = 6 of 32) at the time of 0.18 mg FAi implantation. No patient was found to discontinue systemic therapy during the study period. On average, the data showed that 15.0% of eyes received additional local corticosteroid injections post 0.18 mg FAi during each 3-month study interval.

In their conclusion, Haneots and colleagues indicated the 0.18 mg FAi approach may provide longer-term coverage than the 0.7 mg dexamethasone implant but falls short of the sutured 0.59 mg fluocinolone acetonide intravitreal implant.

“Future areas of study include prospective studies comparing the use of the 0.18 mg FAi alone versus the 0.18 mg FAi in combination with a corticosteroid burst versus systemic immunosuppressive or immunomodulatory therapy in controlling intraocular inflammation,” investigators wrote.

References

1. _{Janetos TM, Koreishi A, Goldstein DA. Long-Term Clinical Outcomes of the 0.18 Mg Fluocinolone Acetonide Intravitreal Implant Following Local Corticosteroid Burst in Noninfectious Uveitis. Ocul Immunol Inflamm. Published online January 9, 2024. doi:10.1080/09273948.2023.2296031}
2. _{Testi I, Pavesio C. Preliminary evaluation of YUTIQ™ (fluocinolone acetonide intravitreal implant 0.18 mg) in posterior uveitis. Ther Deliv. 2019;10(10):621-625. doi:10.4155/tde-2019-0051}