Japanese specialty ophthalmology company Santen Pharmaceutical has reported positive topline results from its SAKURA clinical development programme of OPSIRIA (440µg sirolimus injection) to treat non-infectious uveitis.

OPSIRIA is an intravitreal, locally delivered, targeted, immunoregulator designed to regulate the immune system by the inhibiting mTOR by interrupting the inflammatory cascade that leads to T-cell activation, differentiation and proliferation, and production of interleukin-2 (IL-2), as well as other pro-inflammatory cytokines.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The Sirolimus study assessing double-masked uveitis treatment (Sakura) is the largest Phase III global clinical programme undertaken to examine patients with non-infectious uveitis of the posterior segment.

Under the clinical programme, Study 1 and Study 2 were conducted as multinational, randomised and double-masked trials to evaluate the safety and efficacy of OPSIRIA as monotherapy in patients with non-infectious uveitis of the posterior segment.

"OPSIRIA will address a significant need in the management of non-infectious uveitis of the posterior segment as a locally delivered option for this orphan disease."

The first Phase III SAKURA Study 1 succeeded to establish the efficacy and safety of OPSIRIA as a potential treatment for non-infectious uveitis of the posterior segment.

See Also:

In the second Phase III SAKURA Study 2, the difference in efficacy between the low dose of sirolimus injection and OPSIRIA was not statistically significant, however clinical data provided supportive evidence towards efficacy of the product.

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.

Santen chief scientific officer and global research and development head Naveed Shams said: "OPSIRIA will address a significant need in the management of non-infectious uveitis of the posterior segment as a locally delivered option for this orphan disease.”

The company is planning to file a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OPSIRIA based on the totality of the data from the SAKURA Programme.