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. 

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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.

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