ALPHARETTA, Ga., March 02, 2018 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced that it expects to release topline results from its pivotal Phase 3 clinical trial, called PEACHTREE, of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis before the market opens on Monday, March 5, 2018.
Clearside is pleased to invite all interested parties to participate in a conference call at 8:30 a.m. ET on March 5, during which the PEACHTREE topline results will be discussed. To participate in this conference call, please dial (844) 263-8310 (U.S.) or (213) 358-0959 (international), conference ID 5799948, approximately 10 minutes prior to the start time. A live, listen-only audio webcast of the conference call can be accessed by visiting the “Investor Relations” section at www.clearsidebio.com. An archive of the webcast will be available until June 5, 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 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 loss in these patients.
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 is the proportion of patients with a change from baseline of at least 15 letters in BCVA using the ETDRS scale at 24 weeks. 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.
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a late-stage clinical ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing advanced clinical and preclinical product candidates using a proprietary treatment approach offering unprecedented access to the back of the eye through the suprachoroidal space (SCS™). This offers potentially meaningful treatment benefit to patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration.
Chief Financial Officer