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    SAKURA program reinforces efficacy, safety of intravitreal sirolimus

    Analysis of two phase III studies supports treatment for non-infectious uveitis

    Editor's note: A previously published version of this article incorrectly stated there were two serious adverse events associated with the SAKURA program. There was only one case of confirmed culture-positive endophthalmitis observed with the 880 mcg dose group.

    Results from the Study Assessing double-masKed Uveitis tREAtrement (SAKURA) program support the efficacy and safety of intravitreal sirolimus 440 mcg (Opsiria, Santen) for treating noninfectious uveitis of the posterior segment, said Pauline T. Merrill, MD.

    “The SAKURA program is the largest study of non-infectious uveitis of the posterior segment to date, with almost 600 subjects enrolled in the two sequentially performed phase III randomized, double-masked, multinational studies,” said Dr. Merrill, assistant professor of ophthalmology and section director, uveitis and ocular inflammation, Rush University Medical Center, Chicago.

    “The SAKURA data show that sirolimus 440 mcg has a favorable benefit:risk profile, and it was particularly effective in the population of patients with multiple measures of inflammation,” Dr. Merrill said. “Ocular serious adverse events were not unexpected, and there was a very low incidence of ocular adverse events that are common with intraocular corticosteroids.”

    SAKURA 1 randomized 347 patients to treatment every 2 months with sirolimus 440 mcg, 880 mcg, or 44 mcg as an active control. Inclusion and exclusion criteria were designed to ensure the enrolled subjects had active non-infectious uveitis of the posterior segment.

    Eligible patients had to have a vitreous haze score (modified Standardization of Uveitis Nomenclature scale) ≥ 1.5, best corrected visual acuity (BCVA) ≥ 19 ETDRS letters ( ≥ 20/400) in the study eye and ≥ 20/200 in the fellow eye, and no evidence of active ocular infection.

    The protocol required topical corticosteroids and nonsteroidal immunosuppressive agents to be discontinued prior to enrollment and a compulsory rapid taper of any systemic corticosteroids upon entry.

    Topical corticosteroids were to be tapered to discontinuation by study day 1 and immunomodulators discontinued 30 days prior to day 1. Systemic corticosteroids were allowed only for subjects already receiving them at baseline and had to be rapidly tapered post-baseline.

    The primary efficacy outcome was the proportion of patients with a vitreous haze score of 0 at month 5, and analyses of the data in SAKURA 1 showed superiority of the sirolimus 440 mcg compared with both the 44-mcg active control and 880-mcg dose groups (22.8% versus 10.3% and 16.4%, respectively). The difference between the 440 mcg and 44 mcg doses was statistically significant (p = 0.01).

    Protocol amended


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