The US subsidiary of Japanese ophthalmic pharmaceutical firm Santen Pharmaceutical has released positive results of its SAKURA Study 1, the first of two global Phase III trials evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU).
The company said that SAKURA (Study Assessing double-masKed Uveitis tReAtment) Study 1 met its primary endpoint, which was the proportion of patients achieving a vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale).
Uveitis is an intraocular inflammatory condition that may or may not have an infectious component and is classified by anatomic location in the eye.
Santen chief scientific officer, president and CEO Naveed Shams said NI-PSU is a debilitating disease affects working-aged adults worldwide.
"Currently, there are no FDA-approved non-steroidal treatments for this sight-threatening condition," Shams said.
"We are excited by the SAKURA data and believe sirolimus may provide physicians with the first non-steroidal intravitreal treatment option for their patients suffering with NI-PSU."
SAKURA is an ongoing multinational, multicentre, randomised, double-masked trial evaluating the safety and efficacy of sirolimus.
For SAKURA Study 1, 347 patients with non-infectious posterior, intermediate or panuveitis were enrolled at around 150 sites and eligible patients were randomised into three treatment arms, each receiving different doses of sirolimus by intravitreal injection.
The company said that SAKURA Study 2 continues to enrol patients under the same protocol.
Sirolimus is a mTOR inhibitor, an immunomodulator, which is the same active pharmaceutical ingredient in two FDA approved products.
The two products include Rapamune, an immunosuppressive agent used in renal transplant patients, and CYPHER (Sirolimus-eluting Coronary Stent), approved for improving coronary luminal diameter in patients with symptomatic ischemic disease.