Data From Clearside Biomedical’s Pivotal Phase 3 PEACHTREE Clinical Trial in Macular Edema Associated with Non-Infectious Uveitis to be Presented at the Retina Society 51st Annual Scientific Meeting
Dr. Khurana’s presentation, titled “Suprachoroidally Injected CLS-TA Improves Visual Acuity and Macular Edema in Non-infectious Uveitis: Results of the Phase 3 PEACHTREE Study,” is scheduled for
“We expect to submit an NDA for suprachoroidal CLS-TA to treat macular edema associated with non-infectious uveitis to the
About Suprachoroidal CLS-TA
Suprachoroidal CLS-TA, Clearside’s first investigational treatment, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera. Clearside’s proprietary suprachoroidal treatment approach is designed to enable rapid dispersion of a high amount of medicine to the back of the eye so that adequate medicine reaches and stays at the site of disease and has potential to act longer. This approach has potential to provide efficacy advantages and require fewer treatments and office visits while minimizing harm to the surrounding healthy parts of the eye.
Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved sight-threatening eye diseases that manifest in the retina and the choroid.
PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis.
In the PEACHTREE trial, 47% of patients in the treatment arm who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared to 16% of patients in the control arm who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant (p < 0.001). All key secondary endpoints of the PEACHTREE trial were also achieved.
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
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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 a potential submission of an NDA with the
Chief Financial Officer
Source: Clearside Biomedical, Inc.