Duration 5min, Q&A 3min
Baseline Characteristics of the SAKURA Study. A Phase III, Multicenter, Randomized, Double-Masked Study of Intravitreal Injections of Sirolimus (DE-109) for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment
To describe the baseline characteristics of the subjects in the SAKURA Study. The term uveitis describes a diverse group of conditions that are associated with intra-ocular inflammation. Etiologies of uveitis are endogenous or exogenous and classified by anatomic location in the uvea. Controlling inflammation is of paramount importance regardless of etiology or anatomic location of the disease.
Sirolimus, also known as rapamycin, is a macrolide antibiotic with immuno-suppressive, anti-fungal, and anti-inflammatory properties. A proprietary formulation of sirolimus (DE-109) has been developed at three dose levels intended for intravitreal administration for the treatment of non-infectious uveitis.
The SAKURA development program is a multinational, multicenter, randomized, double-masked Phase 3 protocol assessing the safety and efficacy of three doses of DE-109 (44 µg, 440 µg and 880 µg) administered every 2 months by intravitreal injection in subjects with active, non-infectious uveitis of the posterior segment of the eye. Approximately 500 subjects with active, non-infectious posterior, intermediate or panuveitis will be enrolled and randomized for treatment at approximately 150 sites.
Baseline data for the 333 subjects enrolled as of March 15, 2013 is summarized.
Results and Conclusion
Subjects have been enrolled in 5 different regions: North America (31%), India (32%), Latin America (18%), Europe (15%), Japan (4%). The mean age of the population was 46.2 years; there were more females enrolled than males (58% females). The racial distribution of the subjects enrolled was 47% Caucasian, and 37% Asian, 7% African-American/Black, 4% Other/Mixed and 5% Not reported/Missing.
Based on preliminary data, the majority of subjects enrolled in the SAKURA studies had signs of moderate inflammation with vitreous haze scores of 1.5+ (36%) or 2+ (51%). All subjects had uveitis of the posterior segment at screening (posterior uveitis, intermediate uveitis, or panuveitis). In the majority of subjects, the etiology of the uveitis was reported to be idiopathic; however, the underlying etiology was identified for 35% of subjects.
The demographics and baseline characteristics of the subjects in the SAKURA study demonstrate that the study is representative of the patient population with moderate non-infectious uveitis affecting the posterior segment. Therefore, outcomes of the SAKURA study are expected to be generalizable for patients with this difficult-to-treat cause of vision loss.
[ Keyword ]
Sirolimus (DE-109) / rapamycin / uveitis / non-infectious / intravitreal
[ Conflict of Interest ]