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SAKURA 1 study meets primary endpoint for treatment of noninfectious uveitis
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LONDON — A study of intravitreal sirolimus for the treatment of noninfectious uveitis has achieved its primary endpoint, a speaker said here, reporting the data for the first time worldwide.
At the Euretina Congress, Quan Dong Nguyen, MD, MSc, said a proportion of patients in the phase 3, multicenter, randomized, double-masked SAKURA 1 study had achieved a vitreous haze (VH) score of 0 at month 5 — the study’s primary endpoint — as well as the key secondary endpoint of a VH score of 0.5+ at month 5.
Quan Dong Nguyen
“Sirolimus has a long history of efficacious use in multiple clinical applications, including refractory uveitis,” Nguyen said. “It is currently approved for a number of indications in the U.S., including one to prevent coronary restenosis.”
The parallel design study randomized patients to receive 44 µg, 440 µg or 880 µg of sirolimus at baseline, month 2 and month 4. Thereafter, patients received the 880 µg dose at months 6, 8 and 10. From months 12 to 24, all patients are to be kept on the 880 µg dose; however, frequency of injections will be as needed.
At 5 months, 22.8% of patients in the 440 µg group achieved a VH score of zero, compared with 10.3% in the 44 µg group and 16.4% in the 880 µg group — a statistically significant difference, according to Nguyen.
When looking at the secondary endpoint of proportion of patients with VH score of 0 or 0.5+ at 5 months, “the difference is even more obvious,” Nguyen said, with 52.6% of patients in the 440 µg reaching the endpoint.
Nguyen said more data will be presented at the American Academy of Ophthalmology meeting.
Disclosures: Nguyen’s employer, the University of Nebraska Medical Center, has received research funding from Santen, XOMA, Genentech, pSivida, and Sanofi, among others. Nguyen chairs the Steering Committee for the SAKURA Study.