Abstract
BackgroundPrevention of non-infectious uveitis of the posterior segment (NIU-PS) recurrence using 0.2 μg/day fluocinolone acetonide implant (FAi) was assessed over 3 years (NCT01694186). Outcomes for FAi-treated and fellow eyes with NIU-PS were compared, to evaluate FAi versus conventional treatment strategies.MethodsEligible subjects had >1-year recurrent NIU-PS history and either ≥2 separate recurrences requiring treatment, or corticosteroid therapy (systemic or ocular) in the 12 months preceding study entry. Bilateral disease was present and analysed in 59/87 FAi-treated participants. Recurrence rates, best-corrected visual acuity (BCVA) changes, cataract surgery, intraocular pressure (IOP) events and adjunctive medication use were compared for FAi-treated and fellow eyes.ResultsOver 36 months, more FAi-treated than fellow eyes remained recurrence-free (28.8% vs. 5.1%, P = 0.001; mean 1.9 vs. 4.7 recurrences, respectively, P < 0.0001). FAi-treated eyes gained +9.6 letters BCVA, versus a loss of −4.4 in fellow eyes (P < 0.0001). Systemic medications were given to 42.4% of subjects. Intra/periocular adjunctive injections were lower in FAi-treated than fellow eyes (20.3% vs. 66.1%, P < 0.0001); topical corticosteroid use was also lower in FAi-treated than fellow eyes (27.1% vs 52.5%, P = 0.0041). IOP-related events occurred at similar rates in both FAi-treated and fellow eyes, excepting IOP-lowering surgery (5.1% vs. 15.3%, respectively; P = 0.1251). Cataract surgery occurred in 72.0% of FAi-treated and 37.0% of fellow eyes.ConclusionsIn subjects with bilateral NIU-PS, continuous, low-dose corticosteroid with 0.2 μg/day FAi reduced recurrence and adjunctive medication requirements, and improved vision over 36 months, providing greater protection against ocular inflammation than a reactive approach using standard of care.
Highlights
The current analysis focuses only on patients in the 0.2 μg/day fluocinolone acetonide implant (FAi) treatment arm who had bilateral non-infectious uveitis of the posterior segment (NIU-PS); of the 87 participants treated with the 0.2 μg/day FAi, 59 had bilateral disease
The FAi-treated eyes had a significantly reduced NIU-PS recurrence over 36 months of treatment compared with fellow eyes (71.2% (n = 42) of FAi-treated eyes had a recurrence, compared with 94.9% (n = 56) of fellow eyes (P < 0.0001, Student’s t-test)
The percentage of eyes with ≥2 recurrences over 36 months was substantially higher for fellow than for FAi-treated eyes (78.0% vs. 35.6% (n = 46 vs. 21), respectively; a difference of 42.4%, 95% CI 26.2–58.5; P < 0.0001, Fisher’s Exact test)
Summary
Non-infectious uveitis of the posterior segment (NIU-PS) is an inflammatory disease of the eye, which, if recurrent and untreated or unmanaged, can damage tissue and threaten vision as a result of repeated periods of inflammation [1]. Treatment of NIU-PS using a 0.2 μg/day fluocinolone acetonide implant (FAi, ILUVIEN; Alimera Sciences Ltd., Aldershot, Hampshire) to prevent recurrence of ocular inflammation has previously demonstrated effectiveness in a 36-month study (Study 001; clinicaltrials.gov NCT01694186) [3]. The 0.2 μg/day FAi continuously releases a submicrogram dose of fluocinolone acetonide to the back of the eye over a 36-month period and based on Study 001 and other results [4], the FAi is. Prevention of non-infectious uveitis of the posterior segment (NIU-PS) recurrence using 0.2 μg/day fluocinolone acetonide implant (FAi) was assessed over 3 years (NCT01694186). Outcomes for FAi-treated and fellow eyes with NIU-PS were compared, to evaluate FAi versus conventional treatment strategies
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