Clearside completes Phase 3 enrollment in uveitis
Clearside Biomedical (NASDAQ:CLSD) completed patient enrollment in the Phase 3 PEACHTREE clinical trial, which is designed to evaluate the safety and efficacy of CLS-TA for suprachoroidal administration for the treatment of macular edema associated with non-infectious uveitis.
Patient follow-up in the PEACHTREE trial, which enrolled 160 patients, is six months and the company currently expects to report top-line results in the first quarter of 2018.
Uveitis is a set of inflammatory conditions affecting the eye and a leading cause of blindness. Uveitis occurs in about 350,000 patients in the U.S. and is typically found in both eyes. Macular edema occurs in about one-third of all non-infectious uveitis cases and is a major contributor to vision loss in these patients.
The primary efficacy outcome measure in the PEACHTREE trial is based on improvement in best-corrected visual acuity over the six-month duration of the trial. Safety will be assessed by analyzing the occurrence of adverse events and changes in key safety parameters over the course of the trial. Additional efficacy and safety endpoints also will be evaluated.
Based on feedback from its end-of-Phase 2 meeting with the FDA in May 2015, Clearside believes that PEACHTREE will be the only Phase 3 clinical trial required to support the potential filing of a NDA.
“CLS-TA for the treatment of non-infectious uveitis is our most advanced clinical development program, and completion of patient enrollment in the Phase 3 PEACHTREE trial marks the achievement of a major milestone for our company,” Daniel White, president and CEO, said in a statement.
“With the completion of enrollment in the Phase 3 trial, Clearside is making a giant step toward potentially offering a dynamic new treatment for patients,” he added.
Clearside’s earlier Phase 2 DOGWOOD trial of suprachoroidal CLS-TA in patients with non-infectious uveitis met its primary endpoint, with a statistically significant mean reduction from baseline in retinal thickness of 164 microns at eight weeks following dosing. There was also a statistically significant mean nine-letter improvement in best-corrected visual acuity at eight weeks after dosing.
CLS-TA for suprachoroidal administration, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline for the treatments of unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina.