- Presentations highlighted data analyses across
multiple disease states -
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 multiple oral presentations were given at the 42nd
Annual Macula Society Meeting held February 13-16, 2019 in Bonita
Springs, Florida. The four scientific presentations reviewed
clinical and nonclinical data analyses of Clearside programs in
multiple disease states, including macular edema associated with
uveitis and diabetic macular edema (DME), as well as gene therapy.
Dr. Steven Yeh, Associate Professor, Emory Eye
Center, stated, “Suprachoroidal injections are a novel drug
delivery approach with high selectivity for the retina and choroid.
The compilation of data presented this week continues to
demonstrate the potential advantages this therapeutic
platform may bring to patients suffering from a variety of
blinding eye diseases.”
“With the submission of our new drug application for XIPERE™, we
are working to build awareness of the broad potential of our
suprachoroidal injection platform within the physician community.
While our first potential commercial indication is in uveitic
macular edema, we plan to expand to other areas within uveitis,
diabetic macular edema, and gene therapy. We are grateful for the
support of these investigators who presented the data demonstrating
the potential of our platform in multiple settings,” added Thomas
A. Ciulla, M.D., MBA, Clearside Chief Medical Officer.
Presentation:Dr. Szilard Kiss,
Director of Clinical Research, Associate Professor of
Ophthalmology, Weill Cornell Medical College presented nonclinical
data providing preliminary evidence of the potential for
suprachoroidal administration of gene-based therapies.
Title: |
|
A new approach to ocular
gene therapy: Evaluation of suprachoroidal administration of
non-viral DNA nanoparticles in a rabbit model |
Summary:Suprachoroidal administration of
ellipsoid luciferase non-viral DNA nanoparticles (“DNPs”) produced
activity that was comparable to that seen from subretinal
injections, and significantly greater than that seen from the
negative control or untreated eyes. Suprachoroidally injected DNPs
were well tolerated, showed luciferase expression/activity in the
choroid and retina of rabbit eyes, and provided preliminary
evidence of the potential for suprachoroidal administration of
gene-based therapies. Specifically, suprachoroidal administration
may offer targeted delivery of gene therapies without risks of
vitrectomy and subretinal administration.
Presentation:Dr. Charles
Wykoff, Physician, Surgeon, Co-Director of Greater Houston Retina
Research Center, & Clinical Assistant Professor of
Ophthalmology, Retina Consultants of Houston presented the results
of the Phase 2 TYBEE trial in diabetic macular edema.
Title: |
|
Suprachoroidal CLS-TA
Plus Aflibercept Compared to Aflibercept Monotherapy for Diabetic
Macular Edema: Results of the Randomized Phase 2 TYBEE Trial |
Summary:Therapy of suprachoroidal CLS-TA and
aflibercept showed similar visual and anatomic outcomes compared to
aflibercept monotherapy for the treatment of DME. Combination
dosing was associated with a meaningful reduction in treatment
burden. Ocular adverse events were low for both arms.
Presentation:Dr. Steven Yeh,
Associate Professor, Emory Eye Center reviewed results of XIPERE
from the Phase 3 PEACHTREE study.
Title: |
|
Suprachoroidal CLS-TA
Improves Visual Acuity and Macular Edema in Noninfectious Uveitis:
Results of the Phase 3 PEACHTREE Study |
Summary:In this pivotal, 6-month, Phase 3 trial
in subjects with uveitic macular edema of any anatomic location,
suprachoroidal injection of CLS-TA met its primary endpoint (47% of
subjects gaining 3-lines or greater in BCVA) when compared to sham
control, while also demonstrating an acceptable safety profile.
Presentation:Dr. Seenu
Hariprasad, Chief, Vitreoretinal Service, University of Chicago
presented a combined analysis on the results from the AZALEA,
DOGWOOD, and PEACHTREE studies in macular edema.
Title: |
|
Suprachoroidally
Injected CLS-TA Results in Rapid and Sustained Resolution of
Macular Edema in a Majority of Uveitis Patients: Results of the
AZALEA, DOGWOOD, and PEACHTREE Studies |
Summary:These clinical trials consistently
demonstrated that treatment of uveitic macular edema with
suprachoroidally injected CLS-TA was associated with rapid
improvement in macular edema that was sustained through study
completion. The suprachoroidal approach offers the potential to
more precisely target chorioretinal tissues and facilitate the
treatment of visual loss in patients with uveitic macular
edema.
These presentations are available on Clearside’s
website in the Science section under Programs
(http://www.clearsidebio.com/programs.htm#SCIENCE).
About XIPERE
XIPERE (triamcinolone acetonide suprachoroidal
injectable suspension), formerly known as CLS-TA, is a proprietary
suspension of the corticosteroid triamcinolone acetonide formulated
for administration to the back of the eye via suprachoroidal
injection for the treatment of macular edema associated with
uveitis. Clearside’s patented technology is designed to deliver
drug to the suprachoroidal space located between the choroid and
the outer protective layer of the eye, known as the sclera.
Suprachoroidal injection enables the rapid and adequate dispersion
of medicine to the back of the eye offering the potential for the
medicine to act longer and minimize harm to the surrounding healthy
parts of the eye, thus potentially providing advantageous and
sustained efficacy with a favorable safety profile. A New Drug
Application (“NDA”) was submitted to the U.S. Food and Drug
Administration (“FDA”) in December 2018 for XIPERE, and, if
approved, XIPERE will be the first therapy indicated for macular
edema associated with uveitis.
About Clearside Biomedical
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 such as gene therapy. Clearside is headquartered
in Alpharetta, GA. For more information, please visit
http://www.clearsidebio.com.
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 potential
approval and commercialization of XIPERE in the United States.
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 U.S. Securities and Exchange Commission
(“SEC”) on March 16, 2018, Clearside’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2018, filed with
the SEC on November 8, 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.
Investor and Media Contacts: Jenny Kobin (919)
423-4299Remy Bernarda (415) 203-6386 ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
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