Long‐Term Safety of Intravitreal Sirolimus for the Treatment of Non‐infectious Uveitis (NIU) of the Posterior Segment: 12‐Month SAKURA Study 1 Results

Abstract

PurposeIntravitreal sirolimus significantly reduced inflammation in subjects with NIU of the posterior segment and provided clinically relevant visual benefit, with an acceptable incidence of ocular adverse events (AEs), in the double‐masked period of SAKURA Study 1, the first of 2 phase 3 randomized trials. Here, we report the long‐term (12 month) safety findings from the combined double‐masked and open‐label treatment periods.MethodsSubjects with active NIU of the posterior segment (N = 347) were randomized to 44 μg (active control), 440 μg, or 880 μg injections of intravitreal sirolimus, administered every 2 months. At M6, all subjects transitioned to 880 µg injections every 2 months.Results287 subjects entered the open‐label treatment period and completed the M12 Vitreous Haze assessment. Of these, 211 received ≥1 intravitreal sirolimus injections. Through M12, the most common serious ocular AEs (study eye) occurring in ≥2% of subjects were ocular inflammation (2.9–5.8%), cataract (3.8%), and medication residue (transient drug depot in the visual axis; 2.3%). The mean change in intraocular pressure was <2 mm Hg. The incidence of confirmed endophthalmitis was 0.06%/injection.ConclusionsThere was a low incidence of serious ocular AEs over 12 months with intravitreal sirolimus in this heterogeneous group of subjects with NIU of the posterior segment.