An ongoing phase III, sham-controlled study is investigating intravitreal sirolimus 440 μg (Opsiria, Santen) for the treatment of active, non-infectious uveitis of the posterior segment.
Reviewed by Steven Yeh, MD
The phase III LUMINA study is under way assessing the efficacy and safety of intravitreal sirolimus 440 μg (Opsiria, Santen) administered every 2 months for the treatment of active, non-infectious uveitis of the posterior segment, according to Steven Yeh, MD. Launched in November 2018, the multicenter study plans to enroll 200 patients who are being randomly assigned into three arms (2:2:1) to receive:
- sirolimus 440 μg (experimental test arm),
- a sham procedure (control arm), or
- sirolimus at an undisclosed, fixed dose (within the range of 44 to 880 μg) (dummy arm) every 2 months.
After an initial 6-month, double-masked, controlled period, LUMINA will continue with a 6-month, single-arm, open-label period to allow further evaluation of the efficacy and safety of intravitreal sirolimus 440 μg every 2 months for a longer duration than is appropriate for treatment with placebo or sham injection, explained Dr. Yeh, the M. Louise Simpson Associate Professor of Ophthalmology; director of the Uveitis Service, Emory Eye Center, Atlanta, and an investigator in LUMINA.
Elimination of vitreous haze (VH; VH score of 0) at month 3 is being analyzed as the primary outcome measure. Key secondary outcome measures include VH score of 0 or 0.5+ at month 3 and month 5 and percentage of patients with corticosteroid tapering success with resolution (VH score of 0) at month 3 and month 5.
Steven Yeh, MD
E: [email protected]
Dr. Yeh is a consultant to Santen and Clearside Biomedical.