June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Integrated analysis of two clinical trials
Author Affiliations & Notes
  • Steven Yeh
    Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska, United States
  • Barry Kapik
    Clearside Biomedical Inc, Alpharetta, Georgia, United States
  • Thomas A Ciulla
    Clearside Biomedical Inc, Alpharetta, Georgia, United States
  • Footnotes
    Commercial Relationships   Steven Yeh Bausch + Lomb, Clearside Biomedical Inc, Allergan, Regenxbio, Adverum, Code C (Consultant/Contractor); Barry Kapik Clearside Biomedical Inc, Code E (Employment), Clearside Biomedical Inc, Code I (Personal Financial Interest); Thomas Ciulla Clearside Biomedical Inc, Code E (Employment), Clearside Biomedical Inc, Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 3208 – A0434. doi:
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      Steven Yeh, Barry Kapik, Thomas A Ciulla; Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with uveitis: Integrated analysis of two clinical trials. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3208 – A0434.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Triamcinolone acetonide injectable suspension, for suprachoroidal use (SCS-TA) provides targeted drug delivery to the choroid and retina while minimizing steroid exposure in nontarget tissues. This integrated analysis evaluated SCS-TA for the treatment of macular edema (ME) secondary to noninfectious uveitis (NIU) across two studies.

Methods : Data from a randomized, double-masked, sham-controlled trial (PEACHTREE) and an open-label trial (AZALEA) were pooled. Only those subjects with ME secondary to NIU defined by a central subfield retinal thickness (CST) ≥300 µm with fluid and a best-corrected visual acuity (BCVA) of ≥5 and ≤70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye at baseline were included in the analysis. In both studies, subjects received SCS-TA at baseline and Week 12 and were followed every 4 weeks for 24 weeks. Control subjects received a sham procedure at baseline and Week 12. Outcomes included BCVA, CST, anterior chamber (AC) cells, AC flare, vitreous haze (VH) and adverse events (AEs).

Results : The integrated population included 95 subjects (PEACHTREE 88; AZALEA 7). Increase from baseline in BCVA was greater with SCS-TA vs control with a mean difference of 10.7 letters at Week 24 (P<0.001 for all visits). Proportions of subjects achieving a mean ≥15 letters gain were greater with SCS-TA vs control (47.4% vs 16.7% at Week 24; P<0.001 for all visits). Reduction in CST was greater and more subjects achieved a CST <300 µm with SCS-TA vs control (P<0.001 for all visits). In subjects with baseline inflammation, 72.2%, 71.1% and 72.0% in the SCS-TA group vs 13.6%, 20.0% and 19.0% in the control group achieved resolution of AC cells, flare and VH at Week 24 (all P<0.01). Rescue therapy was required by 12.6% and 73.3% of subjects in the SCS-TA and control groups, respectively. AEs were mostly mild and no treatment-related serious AEs were reported. Overall, incidence of elevated intraocular pressure (IOP) was 20% and 15% in the SCS-TA and control groups (7.4% vs 0% at time of procedure; 12.6% vs 15% post-procedure, control IOP events occurred post rescue). Cataract rates were 7.4% and 6.7% for SCS-TA and control respectively.

Conclusions : In this integrated analysis of two Phase 3 clinical trials, SCS-TA was confirmed to be effective and well tolerated in the treatment of ME associated with NIU.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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