Purpose:

To evaluate intraocular pressure (IOP) in patients with macular edema secondary to noninfectious uveitis (NIU) following suprachoroidal injection of CLS-TA (triamcinolone acetonide injectable suspension), and to compare the IOP events in patients in the control group who were rescued during the PEACHTREE trial versus those who received only treatment with suprachoroidal injections of CLS-TA and no rescue treatment.

Methods:

160 patients were randomized 3:2 to receive suprachoroidal injections of CLS-TA or sham at baseline and week 12, and rescue therapy if needed. Pre-defined criteria were established for the administration of rescue therapy. The type of rescue therapy was at the investigators’ discretion. Pre-injection IOP was assessed every 4 weeks through week 24. Endpoints included ³ 30mmHg IOP as an IOP-related adverse event at any visit, IOP medication use, and surgical intervention for IOP. A post hoc analysis was conducted to compare IOP-related outcomes in patients who only received CLS-TA to patients who received rescue treatment in the control arm.

Results:

In the analyses, 6.3% of patients in the control arm experienced an IOP AE of IOP ≥30 mmHg at any post-baseline visit vs 5.2% in the CLS-TA arm; 9.4% of patients in the control arm were given additional IOP lowering medication versus 7.3% in the in the CLS-TA arm. No surgical intervention was required for an elevated IOP AE in either group. By week 24, 13% of the patients in the CLS-TA arm and 72% in the control arm required rescue therapy (p<0.001). Among subjects who received rescue therapy, intravitreal and periocular corticosteroids were most commonly prescribed. In the post hoc analysis, CLS-TA patients who did not receive rescue treatment experienced lower rates of IOP ³30mmHg at any visit compared to control patients who received rescue therapies (4.8% versus 10.9%). The use of IOP lowering medications in patients who only received CLS-TA was lower than control patients who received rescue therapy (7.2% versus 13.0%).

Conclusions:

Suprachoroidal injections of CLS-TA did not significantly increase IOP relative to sham control in the Phase 3 PEACHTREE trial. Study subjects who only received CLS-TA experienced lower rates of IOP events compared to subjects who also received rescue therapy, supporting a potential beneficial compartmentalization effect of a steroid delivered via the suprachoroidal space.