CLEARSIDE, XIPERE™ and PEACHTREE to be Front and Center at AAO 2018

10/22/18

ALPHARETTA, Ga., Oct. 22, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that two presentations scheduled to be given at the upcoming American Academy of Ophthalmology (“AAO”) 2018 Annual Meeting being held October 27-30 in Chicago, Illinois, will highlight positive data from PEACHTREE, the company’s pivotal Phase 3 trial of XIPERE™ (formerly “suprachoroidal CLS-TA”) in patients with macular edema associated with non-infectious uveitis. 

Rahul N. Khurana, MD, Vitreoretinal Surgeon at Northern California Retina Vitreous Associates, Clinical Associate Professor in Ophthalmology at UCSF Medical Center, and a Principal Investigator for PEACHTREE will be presenting:

  • “Suprachoroidal Delivery of CLS-TA for Uveitic Macular Edema: Results of the Phase 3 PEACHTREE Trial”
    ○  Uveitis Subspecialty Day, in conjunction with the American Uveitis Society
    ○  Date and Time: Saturday, October 27, 2018; 5:06 p.m. CT
    ○  Location: McCormick Place
  • “Phase 3 Efficacy Data of Suprachoroidally Injected CLS-TA for Macular Edema due to Noninfectious Uveitis”
    ○  AAO General Session, Uveitis Original Paper PA034
    ○  Date and Time: Monday, October 29, 2018; 8:30 a.m. CT
    ○  Location: McCormick Place

“I am honored to have this opportunity to present the PEACHTREE data to my fellow clinicians and  researchers and, in so doing, sharing for the first time additional new analyses that I believe provide further support for the already impressive clinical profile of XIPERE in the treatment of uveitic macular edema,” said Dr. Khurana.

About XIPERE

XIPERE, 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.

XIPERE, 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.

About PEACHTREE

PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, comparing XIPERE dosed every 12 weeks to sham control.

The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining 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 sham control arm (p<.001).  All key secondary and additional endpoints of the PEACHTREE trial were also achieved. 

About Uveitis

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.

About Clearside

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases.  Clearside’s proprietary suprachoroidal treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs.  The company’s unique platform for eye disease treatments is inherently flexible and intended to work with established medicines, new formulations of medicines, as well as future innovations.  Clearside’s pipeline includes advanced and pre-clinical product candidates in diseases where macular edema is a common complication, including uveitis, retinal vein occlusion (“RVO”) and diabetic macular edema (“DME”).  Clearside’s most advanced program is in non-infectious uveitis and it expects to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for XIPERE for the treatment of macular edema associated with non-infectious uveitis by the end of 2018.  The company is also conducting two ongoing Phase 3 trials of XIPERE with an intravitreal anti-VEGF agent in patients with RVO.  In addition, Clearside recently announced positive topline results from a Phase 2 clinical trial of XIPERE used with EYLEA® (aflibercept) in patients with DME, and is continuing to analyze additional data from the trial.  Clearside  is headquartered in Alpharetta, GA.  For more information, please visit http://www.clearsidebio.com.  Follow @clearsidebio on Twitter and Linkedin.

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 FDA. 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 December 31, 2017, filed with the SEC on March 16, 2018, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Stephen Kilmer
Investor Relations
(678) 430-8206
stephen.kilmer@clearsidebio.com

Charles Deignan
Chief Financial Officer
(678) 270-4005
charlie.deignan@clearsidebio.com

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Source: Clearside Biomedical, Inc.

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