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Santen releases topline results supporting efficacy, safety of Opsiria for non-infectious uveitis

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Topline results for the SAKURA phase 3 program show the efficacy and safety of Opsiria as a potential treatment for non-infectious uveitis of the posterior segment, Santen announced in a press release.

Opsiria (440 μg sirolimus injection), an intravitreal, locally delivered, targeted immunoregulator, was shown to reduce intraocular inflammation effectively and safely, as measured by vitreous haze, the release said.

Santen now plans to file a new drug application to the FDA based on the data from the program.