CLS-TA provides vision gains in patients with macular oedema
A suprachoroidally injected CLS-TA, an investigational formulation of triamcinolone acetonide, yields significant improvements in vision of patients with macular oedema (ME), according to the results of the phase III PEACHTREE study.
PEACHTREE randomized 160 patients with ME secondary to noninfectious uveitis to receive suprachoroidally injected CLS-TA (n=96) or sham (n=64), administered at baseline and week 12. All patients had a pretreatment best corrected visual acuity (BCVA) score of ≥5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/800 Snellen equivalent) and ≤70 letters read (20/40) in the study eye.
The primary endpoint of an improvement of ≥15 ETDRS letters in BCVA at week 24 occurred with significantly greater frequency in the active treatment than in the control arm (47 percent vs 16 percent; p<0.001).
Results for the secondary endpoint of central subfield thickness were more favourable with CLS-TA, with a mean reduction of 153 μm as compared with 18 μm with sham treatment (p<0.001).
There were no reports of serious adverse events (AEs) related to treatment. Corticosteroid-associated AEs, specifically elevated intraocular pressure, occurred in 11.5 percent on CLS-TA and 15.6 percent on sham. Cataract AE rates were similar (7.3 percent and 6.3 percent, respectively).
According to researchers, the present data support the clinical use of suprachoroidally injected CLS-TA as a new treatment option for patients with ME related to noninfectious uveitis. Furthermore, PEACHTREE opens the way for investigations on suprachoroidal route to deliver therapeutics to choroidal and retinal tissues in a targeted approach.