Mixed results from Santen's Phase III SAKURA program

Japanese ophthalmic pharma specialist Santen Pharmaceutical(TYO: 4536)has announced the top-line results of its SAKURA (Sirolimus study Assessing double-masKed Uveitis tReAtment) global clinical development program designed to confirm the efficacy, safety, and optimal dose between three active doses of sirolimus intravitreal injection as monotherapy for patients with non-infectious uveitis of the posterior segment.

The SAKURA Program met its objective, demonstrating that Opsiria (440 µg sirolimus injection, development code: DE-109) can effectively and safely reduce intraocular inflammation (as measured by vitreous haze).

Findings from SAKURA Study 1, the first Phase III trial, established the efficacy and safety of Opsiria as a potential treatment for non-infectious uveitis of the posterior segment. In SAKURA Study 2, the second Phase III trial, the difference in the effect (vitreous haze) between the low dose of sirolimus injection (44 µg) and Opsiria was not statistically significant, though clinical findings provide supportive evidence confirming the efficacy of the product.