Positive PEACHTREE Data to be Highlighted at EURETINA 2018
September 18 2018 - 4:30PM
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 data from PEACHTREE, its pivotal Phase 3 trial of
suprachoroidal CLS-TA in patients with macular edema associated
with non-infectious uveitis, will be presented by Ron Neumann, MD,
Uveitis Specialist at Maccabi Health Services, Tel Aviv, Israel and
co-Chair of the International Symposium of Ocular Pharmacology and
Therapeutics, during a Uveitis Free Paper session at the upcoming
European Society of Retina Specialists (EURETINA) Congress 2018 in
Vienna, Austria.
Dr. Neumann’s presentation, titled
“Suprachoroidally Injected CLS-TA Improves Visual Acuity and
Macular Edema in Noninfectious Uveitis: Results of the Phase 3
PEACHTREE Study,” is scheduled for Thursday, September 20 at 12:24
p.m. CEST.
“This, the first presentation of the PEACHTREE
data at a scientific meeting outside of the United States, comes at
an opportune time as we plan to pursue marketing authorizations for
suprachoroidal CLS-TA to treat macular edema associated with
non-infectious uveitis in Europe and other jurisdictions,” said
Clearside’s Chief Executive Officer and President, Daniel
White.
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.
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.
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 to the U.S. Food and Drug Administration 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, the timing of a
potential submission of an NDA with the FDA, and Clearside’s plans
to pursue marketing authorizations in Europe and other
jurisdictions. 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 KilmerInvestor Relations(678)
430-8206stephen.kilmer@clearsidebio.com
Charles DeignanChief Financial Officer(678)
270-4005charlie.deignan@clearsidebio.com
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