Clearside Biomedical to Present Data from its Pivotal Phase 3 (“PEACHTREE”) Trial in Macular Edema Associated with Uveiti...
July 16 2018 - 4:30PM
Clearside Biomedical, Inc. (“Clearside”), (NASDAQ:CLSD), a
biopharmaceutical company dedicated to developing treatments that
restore and preserve vision for people with serious eye diseases,
announced today that data from PEACHTREE, its pivotal Phase 3 trial
of suprachoroidal CLS-TA in patients with macular edema associated
with non-infectious uveitis, will be shared as a late-breaking oral
presentation during the 2018 annual meeting of the American Society
of Retina Specialists (“ASRS”), (#asrs2018), July 20-25 in
Vancouver, Canada. The company will host a Medical Affairs
booth (#309) at the ASRS meeting. Positive top-line
results from the PEACHTREE trial were announced in March 2018.
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”,
Steven Yeh, M.D., Louise M. Simpson Professor of Ophthalmology and
Uveitis and Vitreoretinal Surgery Director, Uveitis and Vasculitis
Service at the Emory Eye Center, Emory University, will
present during a late-breaker session on Wednesday, July 25 at
10:40 am Pacific Time.
Separately, at the Ophthalmology Innovation Summit to be held
Friday, July 20, 2018 in conjunction with ASRS, Clearside’s Chief
Executive Officer and President, Daniel H. White, will participate
in a panel discussion on retinal drug delivery.
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.
About PEACHTREE
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.
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 use of suprachoroidal CLS-TA 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 suprachoroidal CLS-TA 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 suprachoroidal CLS-TA used with
EYLEA® (aflibercept) in patients with DME, and is continuing to
analyze additional data from the trial as it becomes
available. 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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