Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical
company revolutionizing the delivery of therapies to the back of
the eye through the suprachoroidal space (SCS®), announced today
that the enrollment and dosing of participants is underway in
ODYSSEY, its randomized, Phase 2b clinical trial of CLS-AX
(axitinib injectable suspension) in neovascular age-related macular
degeneration (wet AMD). CLS-AX is a potent tyrosine kinase
inhibitor combined with administration into the suprachoroidal
space behind the patient’s visual field using Clearside’s patented
SCS Microinjector® providing targeted delivery to the site of
disease.
“The ODYSSEY clinical trial is off to a solid
start with the activation of multiple U.S. based clinical sites,”
said George Lasezkay, Pharm.D., J.D., Clearside’s President and
Chief Executive Officer. “Multiple participants have been enrolled
and we have initiated the randomization of participants to receive
either CLS-AX (1 mg) or aflibercept (2 mg) one month after they
received the first loading dose of aflibercept.”
“This study builds upon the promising data from
our OASIS trial in which 67% of extension study participants in
Cohorts 3 and 4 went at least 6 months without additional
treatment. CLS-AX has the potential to be a twice-a-year treatment
for wet AMD, which could reduce the onerous treatment burden for
patients who currently require more frequent dosing and numerous
office visits with existing approved drugs. We expect to report
topline data in the third quarter of 2024,” concluded Dr.
Lasezkay.
ODYSSEY is a randomized, double-masked,
parallel-group, active-controlled, multi-center, Phase 2b clinical
trial in participants with wet AMD. A total of 60 participants are
expected to be treated for 36 weeks and will be randomized to
either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization
schedule (40 participants in CLS-AX arm and 20 participants in
aflibercept arm). CLS-AX will be administered by suprachoroidal
injection via Clearside’s SCS Microinjector, and aflibercept will
be administered via intravitreal injection. Eligible participants
will be treatment-experienced and will undergo diagnostic imaging
at their screening visit followed by masked reading center
confirmation of persistent active disease. The primary outcome
measure is the mean change from baseline in best corrected visual
acuity. Secondary outcome measures include other changes from
baseline in visual function and ocular anatomy, the need for
supplemental treatment, and treatment burden as measured by total
injections over trial duration. Additional information about the
Phase 2b trial can be found on clinicaltrials.gov
(NCT05891548).
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
as an oral tablet formulation to treat advanced renal cell
carcinoma, 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 and in a Phase 1/2a wet AMD clinical
trial in which CLS-AX was well tolerated and demonstrated an
excellent safety profile. With suprachoroidal administration of
axitinib, there is the potential to achieve prolonged duration and
targeted delivery to affected tissue layers while limiting drug
exposure to the front of the eye. Clearside is developing CLS-AX as
a long-acting therapy for the treatment of retinal diseases.
About Age-Related Macular Degeneration
(AMD)
Age-related macular degeneration causes a
progressive loss of central vision and is the most common cause of
legal blindness in individuals over age 55. Neovascular AMD (wet
AMD) is generally caused by abnormal blood vessels that leak fluid
or blood into the macula, the part of the retina responsible for
central vision, and accounts for the majority of vision loss in
patients with this disorder. In the U.S., approximately 11 million
patients are living with AMD1, and about 10% have the wet form2.
Current treatments require life-long, frequent injections to
maintain efficacy. This treatment regimen tends to cause a
treatment burden for patients resulting in reduced compliance and
under-treatment leading to potentially limited outcomes. In the
U.S., the total economic impact of late-stage AMD is estimated to
be approximately $49 billion, with the majority of costs attributed
to lower productivity related to job loss or job reduction due to
the condition3.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patent protected, proprietary
suprachoroidal space (SCS®) injection treatment approach offers
unprecedented access to the back of the eye, where
sight-threatening disease often occurs. The Company’s unique
platform is inherently flexible and intended to work with
established and new formulations of medications. Clearside’s
patented SCS Microinjector® can deliver a wide variety of drug
candidates into the suprachoroidal space, providing targeted
delivery to potentially improve efficacy and compartmentalization
of medication to reduce or eliminate toxic effects on non-diseased
cells. The SCS Microinjector system comprises a syringe, a
custom-designed hub, and two 30-gauge hollow microneedles of
varying lengths, each less than 1.2 millimeters, optimizing
insertion and suprachoroidal administration of drugs.
About Clearside Biomedical,
Inc.
Clearside Biomedical, Inc. is a
biopharmaceutical company revolutionizing the delivery of therapies
to the back of the eye through the suprachoroidal space (SCS®).
Clearside’s SCS injection platform, utilizing the Company’s
patented SCS Microinjector®, enables an in-office, repeatable,
non-surgical procedure for the targeted and compartmentalized
delivery of a wide variety of therapies to the macula, retina, or
choroid to potentially preserve and improve vision in patients with
sight-threatening eye diseases. Clearside is developing its own
pipeline of small molecule product candidates for administration
via its SCS Microinjector. The Company’s lead program, CLS-AX
(axitinib injectable suspension), for the treatment of neovascular
age-related macular degeneration (wet AMD), is in Phase 2b clinical
testing. Clearside developed and gained approval for its first
product, XIPERE® (triamcinolone acetonide injectable suspension)
for suprachoroidal use, which is available in the U.S. through a
commercial partner. Clearside also strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. For more information, please visit
clearsidebio.com.
Sources1 Pennington, Katie L and DeAngelis,
Margaret M, Eye and Vision, Epidemiology of age-related macular
degeneration (AMD): associations with cardiovascular disease
phenotypes and lipid factors, Dec 22, 2016.2 Prall, F Ryan and
Ciulla, Thomas A, Medscape: Exudative (Wet) Age-Related Macular
Degeneration (AMD), June 16, 2022.3 Retina International, The
Socio-economic Impact of Age-related Macular Degeneration (AMD) in
Bulgaria, Germany, and USA, Oct 12, 2022.
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 clinical development of
CLS-AX, the expected timing of topline results from the ODYSSEY
clinical trial, the potential for CLS-AX to be a twice-a-year
treatment for wet AMD and the other potential benefits of CLS-AX
and other product candidates using Clearside’s SCS Microinjector®.
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, 2022, filed with the U.S.
Securities and Exchange Commission (SEC) on March 14, 2023 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.
Clearside Biomedical (NASDAQ:CLSD)
過去 株価チャート
から 8 2024 まで 9 2024
Clearside Biomedical (NASDAQ:CLSD)
過去 株価チャート
から 9 2023 まで 9 2024