Suprachoroidal use of triamcinolone acetonide: A post-hoc analysis of PEACHTREE to evaluate elevations in intraocular pressure
Chris Or, 1 Carolyn K. Pan, 1 Barry Kapik,2 Thomas Ciulla2, Quan Dong Nguyen,1 for the PEACHTREE Investigators
1. Byers Eye Institute, Stanford University, Palo Alto, CA, USA
2. Clearside Biomedical, Inc., Alpharetta, GA, USA
Purpose: Triamcinolone acetonide injectable suspension, for suprachoroidal use (SCS-TA) provides targeted drug delivery to the choroid/retina while minimizing steroid exposure in nontarget tissues. Safety and efficacy of SCS-TA in the treatment of macular edema (ME) associated with noninfectious uveitis (NIU) was demonstrated in PEACHTREE. We herein evaluated elevations in intraocular pressure (IOP) among SCS-TA subjects and control subjects overall and longitudinally, by visit.
Methods: In PEACHTREE, subjects with ME associate with NIU (N=160) were randomized 3:2 to receive a suprachoroidal injection of SCS-TA (4 mg) or a sham procedure at baseline and Week 12 and followed for 24 weeks. Subjects could receive rescue therapy based on predetermined criteria. In this post hoc analysis, IOP elevations ≥ 10 mm Hg (excluding those values measured immediately following the injection procedure) were determined for subjects categorized by treatment and receipt of rescue. Proportions of subjects requiring ≥ 1 additional IOP-lowering medication or IOP-lowering surgery were summarized.
Results: In PEACHTREE, 83 SCS-TA subjects and 18 control subjects completed the study without rescue (both unrescued SCS-TA and control); 46 control subjects required rescue. First rescue in the control group consisted of corticosteroids administered topically (39.1%), intravitreally (IVT) (30.4%), systemically (13.0%), or periocularly (10.9%). Overall, IVT or periocular corticosteroids were used in 80.4% of rescued control subjects. Over the study, unrescued SCS-TA subjects experienced fewer IOP elevations ≥10 mm Hg from baseline than control subjects who ever received rescue (12.2% vs. 23.9%, respectively), whereas none of the unrescued control subjects experienced an IOP elevation. Longitudinal analysis showed the proportion of subjects with IOP elevations was ≤9.5% in unrescued SCS-TA subjects at any visit compared with ≤3.6% in control subjects prior to rescue and ≤13.3% in rescued control subjects. IOP elevations in the rescued control group were temporally linked with the use of rescue medication. IOP-lowering medication was reported for 7.2% of unrescued SCS-TA vs 13.0% of rescued control subjects and none of the unrescued control subjects. No subjects underwent IOP-lowering surgery.
Conclusion: SCS-TA subjects showed a lower incidence of IOP elevations compared to resuced control subjects, despite the relatively shorter duration of treatment with rescue in control subjects.