Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.
Santen’s SAKURA (Sirolimus study Assessing double-masKed Uveitis tReAtment Study 1 and Study 2 were multinational, randomized and double-blind trials, that lasted for 6 months. Enrolled patients with non-infectious uveitis were randomized into 1 of 3 treatment arms (44µg, 440µg, 880µg).
The Study 1 results demonstrated the safety and efficacy of Opsiria as a potential treatment for non-infectious uveitis of the posterior segment. However, in Study 2 no significant efficacy difference (vitreous haze) was found between the low dose of sirolimus injection (44µg) and Opsiria.
Opsiria regulates the immune system through the inhibition of mTOR which acts by interrupting the inflammatory cascade that leads to T-cell activation, differentiation and proliferation, and production of interleukin-2 (IL-2).
Opsiria was granted orphan drug designation by the Food and Drug Administration (FDA) in 2011. Based on the data from the SAKURA Program, Santen plans to file a New Drug Application (NDA) in the U.S. in early 2017.
For more information visit Santen.com.