CLEARSIDE, XIPERE™ and PEACHTREE to be Front and Center at AAO 2018
October 22 2018 - 3:30PM
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 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 KilmerInvestor Relations(678)
430-8206stephen.kilmer@clearsidebio.com
Charles DeignanChief Financial Officer(678)
270-4005charlie.deignan@clearsidebio.com
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