Japanese specialty ophthalmology company Santen Pharmaceutical has reported positive topline results from its SAKURA clinical development programme of OPSIRIA (440µg sirolimus injection) to treat non-infectious uveitis.
OPSIRIA is an intravitreal, locally delivered, targeted, immunoregulator designed to regulate the immune system by the inhibiting mTOR by interrupting the inflammatory cascade that leads to T-cell activation, differentiation and proliferation, and production of interleukin-2 (IL-2), as well as other pro-inflammatory cytokines.
The Sirolimus study assessing double-masked uveitis treatment (Sakura) is the largest Phase III global clinical programme undertaken to examine patients with non-infectious uveitis of the posterior segment.
Under the clinical programme, Study 1 and Study 2 were conducted as multinational, randomised and double-masked trials to evaluate the safety and efficacy of OPSIRIA as monotherapy in patients with non-infectious uveitis of the posterior segment.
The first Phase III SAKURA Study 1 succeeded to establish the efficacy and safety of OPSIRIA as a potential treatment for non-infectious uveitis of the posterior segment.
In the second Phase III SAKURA Study 2, the difference in efficacy between the low dose of sirolimus injection and OPSIRIA was not statistically significant, however clinical data provided supportive evidence towards efficacy of the product.
Santen chief scientific officer and global research and development head Naveed Shams said: "OPSIRIA will address a significant need in the management of non-infectious uveitis of the posterior segment as a locally delivered option for this orphan disease.”
The company is planning to file a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OPSIRIA based on the totality of the data from the SAKURA Programme.