Purpose: To 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).
Methods: Patients 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).
Results: Over 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.
Conclusion: Approximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9340030 | PMC |
| http://dx.doi.org/10.1136/bjophthalmol-2020-317560 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Safety and Efficacy of CLS-TA by Anatomic Location of Inflammation: Results from the Phase 3 PEACHTREE Clinical Trial.
Ocul Immunol Inflamm
October 2024
Clearside Biomedical, Inc, Alpharetta, Georgia, USA.
Purpose: To explore the efficacy of CLS-TA, a proprietary suprachoroidal injectable suspension of triamcinolone acetonide, in noninfectious uveitis (NIU) with macular edema (ME), categorized by anatomic subtype.
Methods: Patients diagnosed with ME associated with NIU of any etiology and anatomic subtype were eligible for the phase 3 PEACHTREE trial of CLS-TA. Post-hoc analyses were performed, stratified by discrete anatomic subtype of uveitis (anterior, intermediate, posterior, and panuveitis.
OCT outcomes as biomarkers for disease status, visual function, and prognosis in diabetic macular edema.
Can J Ophthalmol
April 2024
Doheny Image Reading and Research Lab, Doheny Eye Institute, Los Angeles, CA; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, CA. Electronic address:
Objective: To evaluate disorganization of retinal inner layers (DRIL), as detected on spectral-domain optical coherence tomography (OCT) images, as a biomarker for diabetic macular edema (DME) activity, visual function, and prognosis in eyes with DME.
Design: Longitudinal prospective.
Methods: Post hoc correlation analyses were performed on data from a phase 2 clinical trial.
Suprachoroidal delivery enables targeting, localization and durability of small molecule suspensions.
J Control Release
September 2022
Clearside Biomedical Inc., 900 North Point Parkway, Suite 200, Alpharetta, GA 30005, United States of America. Electronic address:
Drug delivery to the suprachoroidal space (SCS®) has become a clinical reality after the 2021 FDA approval of CLS-TA, a triamcinolone acetonide injectable suspension for suprachoroidal use (XIPERE®), administered via a microneedle-based device, the SCS Microinjector®. Suprachoroidal (SC) delivery facilitates targeting, compartmentalization, and durability of small molecule suspensions, thereby potentially addressing some of the efficacy, safety, and treatment burden limitations of current retinal therapies. Herein, the design features of the SCS Microinjector are reviewed, along with the biomechanics of SC drug delivery.
View Article and Find Full Text PDFSuprachoroidal Injection of Triamcinolone Acetonide Suspension: Ocular Pharmacokinetics and Distribution in Rabbits Demonstrates High and Durable Levels in the Chorioretina.
J Ocul Pharmacol Ther
August 2022
Clearside Biomedical, Inc., Alpharetta, Georgia, USA.
To compare ocular pharmacokinetics (PK), systemic absorption, and injectability of triamcinolone acetonide (TA) suprachoroidal (SC) and intravitreal (IVT) suspensions. New Zealand White (NZW) rabbits received a bilateral injection of 4 mg TA injectable suspension, TRI (TRIESENCE ; Alcon) through either microneedle-based SC or standard IVT injection. Another group of NZW rabbits received a bilateral SC injection (4 mg) of either TRI or a proprietary TA suspension for SC use, CLS-TA (Clearside Biomedical).
View Article and Find Full Text PDFSuprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE.
Clin Exp Ophthalmol
January 2022
Clearside Biomedical, Alpharetta, Georgia, USA.
Background: This post hoc analysis compared the efficacy and safety of suprachoroidally administered triamcinolone acetonide (CLS-TA) to other commonly available treatments for non-infectious uveitis.
Methods: Results from the PEACHTREE study were compared between subjects randomised to CLS-TA not requiring rescue therapy and those subjects randomised to control, who subsequently required rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickness (CST), treatment emergent adverse events and intraocular pressure (IOP) related safety findings.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!