Santen to launch global study of intravitreal noninfectious uveitis drug

NAPA, Calif. — Santen Inc. is poised to initiate an international phase 3 clinical study to evaluate DE-109 (sirolimus), an intravitreal injection indicated for noninfectious posterior uveitis, the company announced in a news release.

Enrollment for SAKURA (Study assessing double-masked uveitis treatment) opened in May. The multinational, randomized, double-masked clinical trial is designed to gauge the safety and efficacy of three doses of sirolimus.

The drug will be administered every 2 months in subjects with active noninfectious posterior segment uveitis. About 500 subjects with active noninfectious posterior, intermediate or panuveitis will be enrolled at about 150 sites, according to the release.

"We are thrilled about the initiation of the SAKURA Study, as the biggest thing that the program addresses is a major unmet need in the posterior uveitis space," Naveed Shams, PhD, head of global clinical development and medical affairs for Santen's Global Research and Development Division, said in the release. "If proven to be clinically effective, it should significantly impact the quality of life of patients with noninfectious posterior uveitis. Intravitreal sirolimus is expected to significantly reduce the use of systemic and local corticosteroids to treat noninfectious posterior uveitis and hence further reduce the incidence of corticosteroids-induced comorbidities."

Patients will be randomized to three study arms according to dosage levels. The primary endpoint will be a vitreous haze score of zero 5 months after initiation of treatment; subjects will be followed for an additional 7 months to assess safety.