Alay S. Banker
CHICAGO — The results of the integrated SAKURA program showed every-other-month dosing with intravitreal sirolimus improved ocular inflammation and vitreous haze in patients with non-infectious uveitis, according to a speaker here.
Researchers evaluated the safety and efficacy of intravitreal injections of 44 µg and 440 µg sirolimus (Santen) for the treatment of active non-infectious uveitis of the posterior segment. Study of an 880 µg sirolimus dose was abandoned after researchers determined the 440 µg dose to have the better benefit-to-risk profile, Alay S. Banker, MD, said at the American Academy of Ophthalmology meeting.
Intravitreal sirolimus is a locally delivered mTOR inhibitor that inhibits T-cell activation, proliferation and differentiation and increases regulatory T lymphocytes, Banker said.
SAKURA 1 and SAKURA 2, both phase 3 clinical trials, enrolled 347 patients and 245 patients, respectively, together making the SAKURA program the largest clinical trial to date assessing treatment for non-infectious uveitis, Banker said in the presentation.
“The results of the integrated SAKURA program showed that treatment with every other month of 440 µg intravitreal sirolimus resulted in an improvement in vitreous inflammation in the form of vitreous haze, compared with the 44 µg dose,” Banker said.
At 5-month follow-up, 21.2% of patients in the 440 µg dose group experienced vitreous haze scores of zero compared with 13.5% of patients in the 44 µg dose (P = .038). Additionally, 50% of patients in the 440 µg dose group experienced vitreous haze scores of zero to 0.5+ at month 5 compared with 40.4% of patients in the 44 µg dose group, Banker said.
Ocular serious adverse events were manageable, and most were consistent with those associated with the disease state and with the intravitreal injections, he said.
“Most importantly, the changes in the mean IOP were minimal in all those groups up to 24 months,” Banker said. – by Robert Linnehan
Reference: Banker AS. Improvement in vitreous haze in active noninfectious uveitis of the posterior segment with intravitreal sirolimus. Presented at: American Academy of Ophthalmology meeting; Oct. 27-30, 2018; Chicago.
Disclosure: Banker reports he is a consultant for Santen.