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    Pharmacokinetics data suggests sirolimus activity confined to eye

    Findings show no evidence of systemic accumulation with repeated dosing


    Take-home message: Serial measurements of sirolimus blood concentrations after intravitreal injection show the maximum concentration achieved was below the level generally associated with systemic immunosuppression.



    New York—Pharmacokinetics data from SAKURA Study 1—the first of two phase III studies investigating intravitreal sirolimus (Santen) for the treatment of noninfectious uveitis of the posterior segment of the eye—show there is minimal systemic exposure to the immunoregulatory agent, even after repeated dosing, said Daniel F. Rosberger, MD, PhD, MPH.

    “Results from analyses of primary, secondary, and exploratory endpoints in SAKURA Study 1 demonstrated the efficacy of sirolimus as a treatment for non-infectious uveitis of the posterior segment,” said Dr. Rosberger, a SAKURA principal investigator, and clinical assistant professor of ophthalmology, Weill Cornell Medical College, New York.

    The findings from the pharmacokinetics analyses show that the concentrations achieved in the blood never reached the threshold required for systemic immunosuppression, Dr. Rosberger noted.

    “Those results are consistent with the low incidence of systemic adverse events observed in SAKURA Study 1, and indicate that the treatment benefits observed are the result of sirolimus activity at the target site in the eye,” said Dr. Rosberger, a retina specialist in private practice, MaculaCare, New York.

    SAKURA Study 1

    SAKURA Study 1 was a 6-month, double-masked, randomized trial comparing sirolimus 440 and 880 mcg against sirolimus 44 mcg as an active control. Study subjects received a total of 3 intravitreal injections every 2 months during the double-masked treatment period.

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