New intraocular therapies for non‐infectious uveitis

Abstract

SummaryTraditional local treatment of non‐infectious uveitis was limited to steroids with side effects such as cataract and ocular hypertension. Intravitreal (IVT) sirolimus is a novel, non‐steroid, locally delivered mTOR inhibitor under investigation. The SAKURA Program, which represents the largest study of non‐infectious uveitis to date, was comprised of two Phase III (one pivotal, one supportive) multinational randomized double‐masked studies evaluating sirolimus 440 μg vs 44 μg active control in subjects with active NIU‐PS. 80% of subjects had Multiple Measures of Inflammation (MMI) at baseline, defined as vitreous haze (VH) ≥1.5+ and ≥1 of the following: systemic corticosteroids (overall prednisone‐equivalent dose ≥7.5 mg/day), BCVA ≤ 75 ETDRS letters, and/or presence of macular edema. In the integrated ITT population, 21.2% vs 13.5% of subjects receiving 440 μg vs 44 μg achieved VH=0 at Month 5 (p = 0.0381). Among subjects with MMI at baseline, 21.1% vs 8.0% in 440 and 44 μg, respectively, achieved VH = 0 (p = 0.0007). In the SAKURA Program, treatment with 440 μg IVT sirolimus demonstrated statistically significant improvements in VH in subjects with active NIU‐PS, including in subjects with MMI at baseline.