Treating chronic uveitis with fluocinolone acetonide implants

Lynda Charters

Study results show the device offers an effective long-term option for patients.

This article was 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

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.

Related: Noninfectious uveitis: Meeting the challenge

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.

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

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: Confirming uveitis treatment efficacy in study

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.

Related: Why uveitis is a leading and underestimated cause of visual morbidity in patients

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 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.

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
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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