Intravitreal sirolimus effectively reduced vitreous haze in uveitis patients in two studies
FORT LAUDERDALE, Fla. — Two phase 3 studies found 440 µg of intravitreal sirolimus effectively reduced vitreous haze scores to 0 at 5 months’ follow-up for patients with non-infectious uveitis of the posterior segment compared with a control dose of 44 µg of sirolimus, according to a speaker here.
“In summary, the SAKURA program in almost 600 subjects supports the efficacy and safety of 440 µg of intravitreal sirolimus in non-infectious uveitis of the posterior segment,” Pauline T. Merrill, MD, said at the inaugural Retina World Congress.
Pauline T. Merrill
SAKURA 1 and 2 are two phase 3, randomized, double-masked, multinational studies that evaluated the safety and efficacy of intravitreal injections of 440 µg and 880 µg of sirolimus (Santen) compared with 44 µg of sirolimus for the treatment of non-infectious uveitis of the posterior segment. The primary outcome of the study was reduction of vitreous haze to a 0 score.
The SAKURA 1 study included 347 patients randomized to one of the three dose groups. Patients received intravitreal injections every other month. The SAKURA 1 study found the 440 µg dose was more effective, so the SAKURA 2 sequential study was amended to eliminate further evaluation of the 880 µg dosing group, Merrill said.
At month 5 in SAKURA 1, there was a statistically greater response of patients with a decrease of their vitreous haze scores to 0 in the 440 µg dose group compared with the 44 µg dose active control group.
“In SAKURA 2, this difference remained but was numerically smaller. Looking, however, at the integrated population from both studies, we find that again the superiority of the 440 µg dose group did reach statistical significance over the 44 µg active control in this integrated population,” Merrill said.
In a post hoc analysis looking at patients with multiple measures of inflammation, the 440 µg dose group had a statistically significant advantage in reducing vitreous haze scores to 0 at 5 months in study 1, study 2 and the integrated population, she said.
“The SAKURA program showed that 440 µg of intravitreal sirolimus demonstrated a favorable benefit-risk profile. This difference was particularly notable in the population with multiple measures of inflammation. Ocular serious adverse events were not unexpected, and there was a very low incident of any intraocular pressure concerns,” Merrill said. – by Robert Linnehan
Merrill PT. Study assessing double-masked uveitis treatment study 2. Presented at: Retina World Congress; Feb. 23-26, 2017; Fort Lauderdale, Fla.
Disclosure: Merrill reports she received grants, personal fees and non-financial support from Santen during the conduct of the study and receives grants and personal fees from AbbVie.