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.

"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."

"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."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.