Fluocinolone acetonide implant safe for chronic uveitis treatment

Reviewed by Hans W. Andrews, MD

Results from a real-world study of the FDA-approved fluocinolone acetonide 0.18 mg intravitreal implant (Yutiq, EyePoint Pharmaceuticals Inc.) showed that the device was effective for treating chronic noninfectious uveitis over the long term, according to Hans W. Andrews, MD, a resident at the Vanderbilt Eye Institute, in Nashville, Tennessee.

Uveitis is an important cause of visual loss, and corticosteroids remain the standard of care for patients.

When the MUST trial [NCT00132691] compared the use of systemic and regional corticosteroids to treat intermediate uveitis, posterior uveitis, and panuveitis, the best-corrected visual acuities (BCVAs) were very similar throughout the 5-year study.¹

Related: Uveitis: A leading, underestimated cause of visual morbidity in patients

The implant group had better control of intraocular inflammation, but that group had significantly higher incidence rates of cataract and glaucoma.

Based on these results, the investigators concluded that regional therapy was a reasonable approach for treating unilateral uveitis when systemic therapy was ineffective or not feasible.

Clinical trial
The POINT trial (NCT00991029) also evaluated regional steroid (periocular and intravitreal) therapy for uveitic macular edema (ME), and investigators reported significantly reduced ME with intravitreal steroids (triamcinolone and dexamethasone) compared with periocular triamcinolone.

Results also showed improved BCVA by more than 5 letters in the intravitreal groups, but a risk of intraocular pressure (IOP) exceeding 24 mm Hg with intravitreal treatment.² Andrews noted that about 40% of patients in all groups required IOP-lowering medication.

Related: Drainage device offers IOP lowering capabilities at 1 year

The Yutiq implant, which is inserted by an in-office procedure, delivers a low dose (0.2 µg) of fluocinolone acetonide for up to 3 years, lasts significantly longer than the dexamethasone implant (Ozurdex, Allergan), which requires replacement every 2 to 3 months.

The Yutiq implant was evaluated in 2 multicenter, randomized, phase 3 clinical studies in which it was compared with sham therapy.³

Study results reported that the device provided a significant reduction in the recurrence rate of uveitis at 6 and 12 months compared with sham (P < .001 for both comparisons).

Andres reported that in the Yutiq group, significantly (P < .01) more frequent cataract development and a trend toward higher IOP (P = .19).

Related: Tackling the challenge of noninfectious uveitis


Real-world efficacy
Andrews and colleagues conducted a retrospective chart review that included 103 consecutive eyes (68 patients; median age, 59 years) treated with the implant. Posterior uveitis was the most frequent uveitic type.

The patients were evaluated at 1-, 3-, and 6-month intervals for improved visual acuities (VAs) by 2 or more lines, recurrent intraocular inflammation, recurrent or improved ME, and the steroid-sparing effect.

Andrews pointed out that this is the largest study of the implant outside of a clinical trial.

“The VA remained stable after injection of the implant with a trend toward improvement by 6 months,” Andrews said. “The baseline VA was 20/50 that improved to about 20/32. Fifteen eyes had active uveitis at baseline, which resolved in all but 1 patient at 6 months. At baseline, 77% of eyes had no ME, which improved to 88% at 1 month and 89% at 3 months, and was stable at 87% at 6 months. The ME resolved within the first month of treatment in 50% and 62.5% at 3 months.”

Related: Evaluating 3-year recurrence rate in non-infectious posterior segment uveitis post-FAi

Twenty-four patients studied were taking more than 10 mg of oral prednisone daily and/or immunotherapy at baseline.

One month after the Yutiq implant was inserted, 40% of patients decreased the oral prednisolone dose under 10 mg or decreased or discontinued immunotherapy.

At the 3-month time point, that percentage was 57%, and remained stable at 53% at 6 months.

Conclusion
Andrews concluded that the review of the results of the long-term Yutiq implant in 103 eyes showed that the fluocinolone acetonide injectable intravitreal implant is a convenient and effective adjunctive treatment for chronic uveitis.

“The results showed improved vision and ME, suppressed disease activity, and decreased systemic steroid use and need for immunotherapy,” Andrews said.

The investigators are continuing to study the short- and long-term efficacy and adverse effects of this novel therapy.

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Hans W. Andrews, MD
e:hans.w.andrews@vumc.org
This article is adapted from Andrews’ presentation at the American Academy of Ophthalmology’s 2020 virtual annual meeting. Andrews has no financial interest in this subject matter.

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References
1. Kempen JH, Altaweek MM, Drye LT, et al. Benefits of systemic anti-inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis, posterior uveitis, and panuveitis: fifty-four-month results of the multicenter uveitis steroid treatment (MUST) Trial and follow-up study. Ophthalmology. 2015;122(10):1967-1975. doi:10.1016/j/ophtha.2015.06.042

2. Thorne JE, Sugar EA, Holbrook JT, et al. Periocular triamcinolone vs. intravitreal triamcinolone vs. intravitreal dexamethasone implant for the treatment of uveitic macular edema: the PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) trial. Ophthalmology. 2019;126(2):283-295. doi:10.1016/j.ophtha.2018.08.021

3. Jaffe GH, Forster CS, Pavesio CE, et al. Effect of an injectable fluocinolone acetonide insert on recurrence rates in chronic noninfectious uveitis affecting the posterior segment: twelve-month results. Ophthalmology. 2019;126(4);601-610. doi:10.1016/j.ophtha.2018.10.033