Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today that two presentations of Clearside
preclinical and clinical data were given at the virtual American
Academy Ophthalmology (AAO) 2020 Annual Meeting.
Clearside also announced a clinical
characterization of the suprachoroidal injection procedure across
three retinal disorders was published in the Association for
Research in Vision and Ophthalmology (ARVO) peer-reviewed,
Medline-indexed journal, Translational Vision Science and
Technology, which can be accessed here. The data described in this
paper demonstrate that suprachoroidal injection was well accepted
by physician-investigators, and that the device and procedure may
accommodate a wide range of anatomic and demographic variables.
These data suggest that suprachoroidal injection could be readily
adopted in clinical practice for targeted, compartmentalized
delivery of ocular therapies.
“Reflecting on the past year, I am grateful to
our team and the numerous physicians and researchers who have
delivered 33 presentations on our assets and suprachoroidal space
(SCS®) injection platform during 2020,” said Thomas A. Ciulla,
M.D., MBA, Chief Medical Officer and Chief Development Officer. “In
addition to our conference presentations, we have placed four
publications in peer reviewed journals to further educate the
medical community on our clinical progress. This coverage and
attention on our programs have established Clearside as the leader
in suprachoroidal delivery. We look forward to continuing to
advance our suprachoroidal delivery programs with data expected in
2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a
clinical trial, and our integrin inhibitor preclinical
studies.”
Dr. Ciulla continued, “In addition to our
internal progress, we are pleased with the advancements of our
clinical development partners. This weekend at the AAO conference,
suprachoroidal delivery was featured by our gene therapy partner,
REGENXBIO, as well as in a late breaking presentation from Aura
Biosciences in choroidal melanoma. Both of these companies are
using our SCS Microinjector® to deliver their assets into the
suprachoroidal space.”
Title: Suprachoroidal
CLS-AX (axitinib injectable suspension),
as a Potential Long-Acting Therapy for Neovascular
Age-Related Macular Degeneration
(nAMD)Authors:
Robert Bhisitkul; Viral Kansara; Thomas
CiullaConclusions: CLS-AX is intended to be a
targeted therapy to affected tissue layers via suprachoroidal
injection. Axitinib has intrinsic high potency and pan-VEGF
inhibition through receptor blockade. In pharmacokinetic studies,
CLS-AX demonstrated prolonged duration. The U.S. Food and Drug
Administration has accepted Clearside’s Investigational New Drug
Application and a Phase 1/2a clinical trial in wet age-related
macular degeneration (wet AMD) is expected to initiate by the end
of 2020.
Title: Systemic Therapy
and Efficacy of CLS-TA: Results
from the Phase 3 PEACHTREE Clinical Trial
Authors: Quan Nguyen; Thomas Ciulla
Conclusions: These post hoc
results corroborate the pre-specified study analyses in the
PEACHTREE trial. The visual acuity and macular edema improvements
associated with suprachoroidally injected CLS-TA versus the control
in treating macular edema associated with noninfectious uveitis,
was noted regardless of administration of systemic therapy at
baseline.
About Clearside’s Suprachoroidal Space
(SCS®) Injection
Platform
Clearside’s patented, proprietary suprachoroidal
space (SCS) injection treatment approach offers unprecedented
access to the back of the eye where sight-threatening disease often
occurs. Clearside’s proprietary SCS Microinjector® can be used to
inject a wide variety of drug candidates that are specifically
formulated to be delivered via suprachoroidal injection.
Clearside’s unique platform is inherently flexible and intended to
work with established medications, new formulations of medicines,
as well as future innovations such as gene therapy.
About CLS-AX (axitinib
injectable suspension)
CLS-AX (axitinib injectable suspension) is a
proprietary suspension of axitinib for suprachoroidal injection.
Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to
treat renal cell cancer that achieves pan-VEGF blockade, directly
inhibiting VEGF receptors-1, -2, and -3 with high potency and
specificity. Clearside believes this broad VEGF blockade may have
efficacy advantages over existing retinal therapies by acting at a
different level of the angiogenesis cascade, and may benefit
patients who sub-optimally respond to current more narrowly focused
anti-VEGF therapies. Suprachoroidal injection of this proprietary
suspension of axitinib has demonstrated meaningful potential in
preclinical studies in multiple species. Preclinical results from
Clearside and independent investigators have shown pharmacodynamic
effect with reduced growth of experimental neovascularization and
decreased fluorescein leakage. With suprachoroidal administration
of axitinib, there is the potential to achieve prolonged duration
and targeted delivery to affected tissue layers. Clearside is
developing CLS-AX as a long-acting therapy for the treatment of wet
AMD.
About
XIPERE™ (triamcinolone
acetonide suprachoroidal injectable suspension)
XIPERETM (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 and being investigated
for the treatment of macular edema associated with non-infectious
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. Bausch + Lomb, a leading global eye health
business of Bausch Health Companies Inc. (“Bausch Health”)
(NYSE/TSX: BHC), has the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada and exclusive options for the right to commercialize and
develop XIPERE in Europe and the United Kingdom, Australia and New
Zealand, and South America and Mexico (through a license agreement
between Clearside and Bausch Health’s affiliate). Arctic Vision, a
specialty ophthalmology company based in China, has the exclusive
license for the commercialization and development of XIPERE in
Greater China and South Korea.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector® targets the suprachoroidal space (SCS®) and offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. Clearside’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications, as well as future therapeutic innovations such as gene
therapy. For more information, please visit
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 statements regarding the development and
potential benefits of CLS-AX and XIPERE, including the timing of
initiation of and data from the Phase 1/2a clinical trial for
CLS-AX in wet AMD, as well as the timing of data from preclinical
studies in Clearside’s integrin inhibitor program. 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, uncertainties regarding the
COVID-19 pandemic and other risks and uncertainties that are
described in Clearside’s Annual Report on Form 10-K for the year
ended December 31, 2019, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 13, 2020, Clearside’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2020, filed with the SEC on November 10, 2020 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 Remy Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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