PMID- 36399237 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230115 IS - 2193-8245 (Print) IS - 2193-6528 (Electronic) VI - 12 IP - 1 DP - 2023 Feb TI - Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. PG - 577-591 LID - 10.1007/s40123-022-00603-x [doi] AB - INTRODUCTION: Macular edema, a common complication of uveitis, may result in vision loss. The aim of this analysis was to report integrated phase 3 trial data for triamcinolone acetonide injectable suspension for suprachoroidal use (SCS-TA) in the treatment of macular edema secondary to noninfectious uveitis using strict inclusion criteria. METHODS: This analysis included patients with central subfield thickness (CST) >/= 300 microm and best-corrected visual acuity (BCVA) of >/= 5 and /= 1 study treatment in either PEACHTREE (randomized, double-masked SCS-TA or sham control) or AZALEA (open-label SCS-TA). Patients received SCS-TA 4.0 mg (0.1 ml of 40 mg/ml) or control at baseline and week 12. RESULTS: In the SCS-TA group (n = 95), 47.4% of patients gained >/= 15 ETDRS letters from baseline to week 24 versus 16.7% of patients in the control group (n = 60; P < 0.001). Mean change in BCVA in the SCS-TA group was 9.6 letters at week 4 and 13.9 letters at week 24. CST also improved rapidly in the SCS-TA group (mean change: - 158.4 microm at week 4), with sustained reduction throughout the study (mean change: - 163.9 microm at week 24 versus - 19.3 microm in the control group; P < 0.001). No treatment-related serious adverse events (AEs) were reported. Incidence of AEs pertaining to elevated intraocular pressure was 12.6% and 15.0% in the SCS-TA and control groups, respectively; incidence of cataract formation/worsening AEs was 7.4% and 6.7%, respectively. CONCLUSION: In this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02595398, NCT03097315. CI - (c) 2022. The Author(s). FAU - Yeh, Steven AU - Yeh S AUID- ORCID: 0000-0002-5417-7771 AD - Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA. FAU - Henry, Christopher R AU - Henry CR AUID- ORCID: 0000-0003-4011-3758 AD - Retina Consultants of Texas, Houston, TX, USA. AD - Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA. AD - Department of Ophthalmology, University of Texas Health Science Center at Houston, Houston, TX, USA. FAU - Kapik, Barry AU - Kapik B AUID- ORCID: 0000-0001-9655-7169 AD - Clearside Biomedical, Inc., 900 North Point Parkway, Suite 200, Alpharetta, GA, 30005, USA. FAU - Ciulla, Thomas A AU - Ciulla TA AUID- ORCID: 0000-0001-5557-6777 AD - Clearside Biomedical, Inc., 900 North Point Parkway, Suite 200, Alpharetta, GA, 30005, USA. thomas.ciulla@clearsidebio.com. LA - eng SI - ClinicalTrials.gov/NCT02595398 SI - ClinicalTrials.gov/NCT03097315 GR - Study funding/Clearside Biomedical, Inc./ GR - Funding for editorial/writing assistance/Bausch + Lomb/ GR - Payment for rapid service fee/Bausch + Lomb/ PT - Journal Article DEP - 20221118 PL - England TA - Ophthalmol Ther JT - Ophthalmology and therapy JID - 101634502 PMC - PMC9834475 OTO - NOTNLM OT - Central subfield thickness OT - Macular edema OT - Suprachoroidal OT - Triamcinolone acetonide OT - Uveitis EDAT- 2022/11/19 06:00 MHDA- 2022/11/19 06:01 PMCR- 2022/11/18 CRDT- 2022/11/18 11:15 PHST- 2022/09/21 00:00 [received] PHST- 2022/10/18 00:00 [accepted] PHST- 2022/11/19 06:00 [pubmed] PHST- 2022/11/19 06:01 [medline] PHST- 2022/11/18 11:15 [entrez] PHST- 2022/11/18 00:00 [pmc-release] AID - 10.1007/s40123-022-00603-x [pii] AID - 603 [pii] AID - 10.1007/s40123-022-00603-x [doi] PST - ppublish SO - Ophthalmol Ther. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.