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Suprachoroidal CLS-TA Improves Visual Acuity and Macular Edema in Noninfectious Uveitis: Results of the Phase 3 PEACHTREE Study
Presenter:
Quan Dong Nguyen, MD, MSc.
Authors:
Quan Dong Nguyen, MD, MSc, FAAO; Diana Do, MD
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Byers Eye Institute, Stanford University, Palo Alto, CA
Affiliation:
Purpose: To evaluate the efficacy and safety of suprachoroidal injection of CLS-TA, a proprietary triamcinolone acetonide (TA) injectable suspension, in subjects with macular edema associated with noninfectious uveitis. The therapeutic benefit and safety of suprachoroidal CLS-TA for macular edema due to noninfectious uveitis, utilizing a novel drug delivery approach with high chorioretinal selectivity, will be described.
Methods: In a double-masked, prospective, multicenter study, 160 subjects with macular edema associated with noninfectious uveitis of any anatomic subtype (anterior, intermediate, posterior, or panuveitis) were randomized 3:2 either to suprachoroidal injections of CLS-TA (4.0 mg; n=96) or sham procedures (n=64) at Day 0 and at Week 12. Evaluations were every 4 weeks through Week 24. The primary endpoint was the proportion of subjects with ≥ 15 ETDRS letter improvement from baseline in BCVA at Week 24.
Results: The proportion of subjects gaining ≥15 ETDRS letters in BCVA at Week 24 from Baseline in the CLS-TA arm (45/96, 46.9%) was significantly greater than in the sham arm (10/64, 15.6%, p < 0.001). Mean change from baseline in BCVA and in central subfield thickness was significantly improved in the CLS-TA arm compared to the control arm at all monthly assessments (at week 24: 13.8 vs 3.0 ETDRS letters, p < 0.001; -152.6 microns vs -17.9 microns, p < 0.001). There were 3 serious adverse events considered unrelated to treatment. Elevated IOP occurred in 11.5% of subjects in the CLS-TA group and 15.6% of subjects in the control group. All IOP increases in the control group were associated with local corticosteroid rescue treatment. Elevated IOP was managed with topical IOP-lowering medication when treatment was necessary. Cataract AEs were comparable in subjects in the CLS-TA arm (7.3%) and control arm (6.3%).
Conclusion: In this pivotal, 6-month, phase 3 trial in subjects with uveitic macular edema of any anatomic location, suprachoroidal injection of CLS-TA met its primary endpoint (% of subjects gaining ≥15 ETDRS letters in BCVA) when compared to sham control while also demonstrating an acceptable safety profile.