Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA)

Abstract

PurposeTo assess the extended efficacy and safety of suprachoroidal triamcinolone acetonide injectable suspension (CLS-TA) among patients with macular oedema (ME) secondary to non-infectious uveitis (NIU).MethodsPatients with uveitic ME were treated with suprachoroidal CLS-TA at baseline and week 12 of the Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial (PEACHTREE) study. Time to rescue was evaluated over 24 additional weeks for MAGNOLIA. Safety data, visual acuity and retinal central subfield thickness (CST) reduction were also evaluated. Of the 53 eligible patients (46 CLS-TA and 7 control), 33 patients were enrolled (28 CLS-TA and 5 control).ResultsOver the entire 48-week period for PEACHTREE and MAGNOLIA, the median time to rescue therapy was 257 days versus 55.5 days for the CLS-TA and sham-control arms, respectively. Of 28 CLS-TA treated patients who participated in MAGNOLIA, 14 (50%) did not require rescue therapy through approximately 9 months after the second treatment. Among CLS-TA patients not requiring rescue, there was a mean gain of 12.1 letters and mean CST reduction of 174.5 µm at week 48. No serious adverse events related to study treatment were observed.ConclusionApproximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.

Suprachoroidal Space Triamcinolone Acetonide: A Review in Uveitic Macular Edema

“…This section focuses on the efficacy of SCS triamcinolone acetonide in the pivotal phase III PEACHTREE trial [ 15 ] and its extension (MAGNOLIA) [ 16 ]. SCS triamcinolone acetonide improved visual acuity in a phase I/II trial [ 17 ] and reduced central subfield thickness (CST) in a phase II trial (DOGWOOD) [ 18 ] in patients with macular edema due to non-infectious uveitis; these data are not discussed further.…”

“…Patients from selected centers completing PEACHTREE without requiring rescue therapy were enrolled in MAGNOLIA for an additional 24 weeks’ follow-up ( n = 28 in the SCS triamcinolone acetonide and 5 in the sham group) with no further treatment [ 16 ]. The primary endpoint of MAGNOLIA was time to rescue therapy from the date of first study treatment administration in PEACHTREE.…”

“…The primary endpoint of MAGNOLIA was time to rescue therapy from the date of first study treatment administration in PEACHTREE. During MAGNOLIA, 11 (39%) patients in the SCS triamcinolone acetonide group and three (60%) in the sham group required rescue therapy; 14 (50%) of patients in the SCS triamcinolone acetonide group did not require rescue therapy for up to 9 months after the second dose [ 16 ].…”

Drug Delivery via the Suprachoroidal Space for the Treatment of Retinal Diseases

“…The study enrolled 33 eyes—28 CLS-TA and 5 control. The median time to rescue therapy was 257 versus 55.5 days in the treatment and control groups, respectively, and approximately 50% of treated patients did not require additional therapy up to 9 months following last CLS-TA administration [ 76 ].…”

A Review of Ocular Drug Delivery Platforms and Drugs for Infectious and Noninfectious Uveitis: The Past, Present, and Future

“…Much like the preclinical studies, minimal systemic absorption was found [ 60 ]. In the most recent phase III trials, the suprachoroidal injection resulted in a significant reduction in macular edema and visual improvement compared to sham injections [ 30 , 61 ]. The injection has been marketed to target and treat macular edema; however, there is hope that this new method could be another approach to treating posterior segment inflammation but with a lower side effect profile than other steroid-based therapies.…”