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Stephan R Thurau; 24-Month Safety Outcomes in SAKURA Study 1: Treatment of Non-infectious Uveitis (NIU) of the Posterior Segment With Intravitreal Sirolimus. Invest. Ophthalmol. Vis. Sci. 2016;57(12):1884.
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© ARVO (1962-2015); The Authors (2016-present)
SAKURA Study 1 is a phase 3, randomized, multinational, 24-month study assessing the safety and efficacy of intravitreal sirolimus as monotherapy for the treatment of active NIU of the posterior segment. In the double-masked phase, statistically significant improvements on the primary and key secondary vitreous haze endpoints were observed with injections of the 440 µg dose compared with a 44 µg active control dose. Here, we report long-term safety outcomes through month 24.
347 subjects (348 eyes) with active NIU of the posterior segment (baseline vitreous haze score >1+ and best corrected visual acuity ≥19 ETDRS letters in the study eye) were randomized 1:1:1 to intravitreal sirolimus injections of 44 μg, 440 μg, or 880 μg administered every 2 months, followed by open-label injections of 880 μg at Months 6, 8, and 10. Starting at Month 12, subjects who achieved clinical benefit continued to receive 880 μg PRN injections at a minimum 2-month injection interval if they met prespecified retreatment criteria. Safety assessments were conducted through Month 24.
A total of 60.6% (211/348) of study eyes received treatment in the open-label treatment or PRN retreatment periods. The percentages of subjects who received open-label treatment or entered the open-label PRN retreatment period were balanced among the 3 treatment groups. Overall, the incidence of ocular adverse events (AEs) and serious ocular AEs decreased in the entire open-label treatment periods (Months 6-24) compared with the double-masked treatment period. Through Month 24, serious ocular AEs occurring at an incidence of >2% were uveitis (5.8%), posterior uveitis (3.8%), non-infectious endophthalmitis (3.2%), cataract (2.3%), and medication residue (transient drug depot in the visual axis, 2.3%). Serious ocular AEs >2% related to study medication were uveitis (2.6%), non-infectious endophthalmitis (2.3%), and medication residue (2.3%). Conjunctival hemorrhage (15.9%) was the most common AE related to the injection procedure. Glaucoma was reported as a serious AE in 2 subjects.
Intravitreal sirolimus was associated with a low incidence of AEs over 24 months of treatment in this population of subjects with active NIU of the posterior segment.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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