Clearside announces CLS-TA achieves endpoints in phase 3 PEACHTREE trial
Clearside Biomedical released positive topline results from a pivotal phase 3 clinical trial of suprachoroidal CLS-TA for patients with macular edema associated with noninfectious uveitis.
The randomized, masked, sham-controlled PEACHTREE trial included 160 patients, of which 96 were randomized to the treatment arm and received two 4 mg doses of suprachoroidal CLS-TA 12 weeks apart. The other 64 patients were randomized to undergo sham procedures at the same 12-week interval, according to a company press release.
Suprachoroidal CLS-TA is a proprietary suspension of triamcinolone acetonide that is administered to the back of the eye via the suprachoroidal space.
Patients in both arms were evaluated every 4 weeks for 24 weeks; 155 patients completed the entire evaluation period.
Forty-seven percent of patients who received suprachoroidal CLS-TA gained at least 15 letters in best corrected visual acuity from baseline to week 24 (P < .001), the primary endpoint of the study, compared with 16% of patients who underwent the sham procedure.
The mean improvement for the treatment arm was 9.6 letters gained at week 4 and 13.7 letters at week 24 compared with 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm.
For the secondary endpoint, suprachoroidal CLS-TA resulted in a mean reduction of 157 µm in central subfield thickness from baseline at week 24 compared with a 19 µm mean reduction in the control arm (P < .001).
No treatment-related serious adverse events were reported in the suprachoroidal CLS-TA arm.
The company expects to submit an FDA new drug application for suprachoroidal CLS-TA for macular edema associated with uveitis in the fourth quarter.