Results from an integrated analysis of data from the SAKURA (Sirolimus study Assessing double masKed Uveitis tReAtment) program support the efficacy and safety of intravitreal sirolimus 440 mcg (Opsiria, Santen) as a novel local treatment for non-infectious uveitis of the posterior segment.
Data showed sirolimus 440 mcg had a more favorable benefit:risk profile than the 44 mcg active control, was associated with a very low incidence of IOP elevation, and facilitated successful tapering of existing systemic corticosteroid therapy. The FDA is reviewing the New Drug Application for intravitreal sirolimus and has set an action date of Dec. 24, 2017 to complete its review, according to the company.
“Based on the efficacy and safety of intravitreal sirolimus, I look forward to its approval and the ability to use it to treat patients with non-infectious posterior segment uveitis,” said Raj Maturi, MD, Midwest Eye Institute, Indianapolis, an investigator in the SAKURA program. “Sirolimus, unlike corticosteroids, does not appear to be associated with an increased risk for glaucoma or cataract formation.”