SonomaEye-full-color-vector[2].png

Thank you for your submission!

Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Outcomes by anatomic subtypes in PEACHTREE

Hashem Ghoraba

Presenter:

Hashem Ghoraba, 1 Quan Dong Nguyen,1 Barry Kapik,2 Thomas Ciulla2

Authors:

Affiliation:

1. Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, USA

2. Clearside Biomedical, Inc., Alpharetta, GA, USA.

Purpose: To evaluate the efficacy and safety of triamcinolone acetonide injectable suspension for suprachoroidaluse in patients with anterior-, intermediate-, posterior-, and pan-uveitis.

Methods: In PEACHTREE, 160 NIU subjects with ME were randomized 3:2 to SCS-TA or sham procedure at baseline and week 12 and were followed for 24 weeks. Subjects diagnosed with NIU of any anatomic subtype, including anterior-, intermediate-, posterior-, and pan-uveitis, were included. Herein, efficacy endpoints, including changes in best corrected visual acuity (BCVA), central subfield retinal thickness (CST), and safety endpoints, including adverse event (AE) reports and intraocular pressure (IOP), were evaluated in subjects diagnosed with NIU in a single anatomic location.

Results: Of subjects in the SCS-TA and control arms, 13 vs 7 had anterior uveitis, 21 vs 15 had intermediate uveitis, 20 vs 11 had posterior uveitis, and 30 vs 24 had panuveitis. Across NIU subtypes, at week 24, SCS-TA-treated subjects showed significant improvements from baseline in BCVA ranging from 12.1 to 15.9 letters, while control subjects showed changes ranging from -1.6 to 9.1 letters, with significant between-treatment differences among subjects diagnosed with posterior- or pan-uveitis (P≤0.024). Similarly, changes in CST among SCS-TA subjects were significantly improved from baseline for all anatomic subtypes and ranged from -120.1 to -189.0 µm in SCS-TA-treated subjects vs -20.3 to 10.2 µm in control subjects, with significant between-treatment differences among intermediate-, posterior- and pan-uveitis subtypes (P≤0.014). Reports of AEs appeared similar between treatments by anatomic subtype. At week 24, SCS-TA-treated subjects showed IOP changes of 0.5 to 3.1 mm Hg compared to -1.2 to 1.7 mm Hg in control subjects.

Conclusion: Treatment with SCS-TA resulted in significant BCVA and CST improvements from baseline in all anatomic NIU subtypes; BCVA improvements with SCS-TA were significantly better versus control in posterior- and pan-uveitis while CST improvement with SCS-TA were significantly better versus control for most anatomic NIU subtypes. Safety findings were comparable across discreet NIU subtypes.

Attachments: