Clearside Biomedical to Present Data from its Pivotal Phase 3 (“PEACHTREE”) Trial in Macular Edema Associated with Uveitis at the 2018 American Society of Retina Specialists Annual Meeting
In this, the first public presentation of data from the PEACHTREE trial at a medical conference, titled “Suprachoroidally Injected CLS-TA Improves Visual Acuity and Macular Edema in Noninfectious Uveitis: Results of the Phase 3 PEACHTREE Study”,
Separately, at the Ophthalmology Innovation Summit to be held
Neither Dr. Yeh’s presentation at ASRS or Mr. White’s panel discussion at OIS@ASRS will be webcast.
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. Patients were randomized to receive two unilateral suprachoroidal CLS-TA injections or two unilateral suprachoroidal sham procedures approximately 12 weeks apart. The primary efficacy outcome measure in the trial was the proportion of patients with a change from baseline of at least 15 letters in best corrected visual acuity (“BCVA”), as measured using the Early Treatment of Diabetic Retinopathy Study (“ETDRS”) scale at 24 weeks. Safety was 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 were also evaluated.
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 United States and is typically found in both eyes. Macular edema is the build-up of fluid in the macula, an area in the center of the retina responsible for sharp, straight-ahead vision. Fluid buildup causes the macula to swell and thicken, which distorts vision. Macular edema occurs in approximately one-third of all non-infectious uveitis cases and is a major contributor to vision impairment and vision loss in these patients.
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 a potential submission of an NDA with the
(678) 430-8206 firstname.lastname@example.org
Chief Financial Officer
(678) 270-4005 email@example.com
Source: Clearside Biomedical, Inc.