Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial

ABSTRACT

Purpose

To study the efficacy and safety of suprachoroidal CLS-TA (proprietary suspension of triamcinolone acetonide) in uveitic macular edema (UME) with and without concurrent systemic corticosteroid or steroid-sparing therapy (ST).

Methods

Post hoc analysis of the PEACHTREE phase 3 randomized trial.

Results

Among UME patients receiving no ST, at week 24, mean BCVA change was +15.6 letters in 68 CLS-TA patients versus +4.9 letters in 49 sham-control patients (p < .001), while mean CST change was −169.8 µm versus −10.3 µm, respectively (p < .001). Among patients receiving ST, at week 24, mean BCVA change was +9.4 letters in 28 CLS-TA patients versus −3.2 letters in 15 sham-control patients (p = .019), while mean CST change was −108.3 µm versus −43.5 µm, respectively (p = .190). No SAEs related to treatment were reported.

Conclusions

A clinically meaningful benefit of CLS-TA was noted in UME patients, regardless of concurrent ST usage.

Abbreviation and Acronyms

CST = central subfield thickness; BCVA = best corrected visual acuity; ME = macular edemaI; IVT = intravitreal; AE = adverse event; FA = fluocinolone acetonide; SD-OCT = spectral-domain optical coherence tomography; NIU = noninfectious uveitis; SAE = serious adverse event; TEAE = treatment emergent adverse event; ITT = intent to treat; CI = confidence interval

KEYWORDS:

• Suprachoroidal
• CLS-TA
• Systemic, corticosteroid therapy
• Systemic, steroid-sparing therapy
• Uveitic macular edema

Acknowledgments

The trial was designed jointly by the investigators and the sponsor (Clearside Biomedical, Inc; Alpharetta, GA). The investigators collected the data, and the sponsor conducted the data analyses. All authors had full access to the data; there was an agreement between the investigators and the sponsor to not disclose any trial information that was not publicly available. All authors reviewed and provided feedback on the manuscript drafts and made the decision to submit the manuscript for publication; the sponsor also reviewed and approved the manuscript. All authors vouch for the completeness and accuracy of the data and analyses and affirm that the trial was conducted and reported with fidelity to the protocol.

(Funded by Clearside Biomedical, Inc.; PEACHTREE ClinicalTrials.gov number NCT02595398)

Disclosure statement

Dr. Merrill reports receiving grant support from Clearside Biomedical and personal fees from Santen, Gilead, Eyepoint, and Abbvie. Dr. Henry reports receiving personal fees from Clearside Biomedical and Bausch and Lomb. Dr. Nguyen reports receiving grant support from Genentech, Regeneron, and Santen. Dr. Reddy report receiving personal fees from Clearside Biomedical. Mr. Kapik is an employee of Clearside Biomedical and holds stock in the company. Dr. Ciulla is an employee of Clearside Biomedical and holds stock in the company.

Prior presentations

Data from this manuscript were presented at the Retina Society Annual Meeting 2020, the Association for Research in Vision and Ophthalmology Annual Meeting 2020, and the American Society of Retina Specialists Annual Meeting 2020.

Synopsis

This post hoc analysis demonstrated suprachoroidal injection of investigational triamcinolone acetonide (CLS-TA) in PEACHTREE provided clinically relevant benefits compared to control regardless of the presence of systemic therapies.

Additional information

Funding

This study was funded by Clearside Biomedical, Inc. (Alpharetta, GA). The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, and interpretation of the data, preparation, and review of the manuscript.