Clearside Biomedical Announces Completion of Patient Enrollment in Pivotal Phase 3 PEACHTREE Clinical Trial of CLS-TA for Suprachoroidal Administration in Patients with Macular Edema Associated with Non-Infectious Uveitis
07 August 2017
Clearside Expects to Report Top-Line Results in Q1-2018
Uveitis, a set of inflammatory conditions affecting the eye, is one the world’s leading causes of blindness. Uveitis occurs in about 350,000 patients in
The PEACHTREE trial, a randomized, masked, sham-controlled Phase 3 trial, has enrolled 160 patients with macular edema associated with non-infectious uveitis. The primary efficacy outcome measure in the trial is based on improvement in best corrected visual acuity over the 6-month duration of the clinical 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 will also be evaluated. Based on feedback from its end-of-Phase 2 meeting with the
“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,” said
As previously reported, Clearside’s 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 (p=0.002). There was also a statistically significant mean 9 letter improvement in best corrected visual acuity at eight weeks following dosing (p=0.0004).
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.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Clearside’s product candidates, the potential attributes and benefits of Clearside’s product candidates and the timing of top-line results from Clearside’s PEACHTREE trial. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended