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
completion of dosing in Cohorts 3 and 4 of OASIS, its Phase 1/2a
clinical trial of CLS-AX (axitinib injectable suspension) in
patients with neovascular age-related macular degeneration (wet
AMD).
OASIS is a U.S.-based, multi-center, open-label,
dose-escalation trial in wet AMD patients to assess the safety and
tolerability of a single dose of CLS-AX administered by
suprachoroidal injection. The study enrolled 8 patients in Cohort 3
and 8 patients in Cohort 4, all of whom received aflibercept at
their first visit and a single dose of CLS-AX at their second visit
one month later. In total, there were 27 patients in four cohorts
enrolled in OASIS, with escalating doses of CLS-AX (in mg): Cohort
1 at 0.03 (n=6); Cohort 2 at 0.10 (n=5); Cohort 3 at 0.50 (n=8);
Cohort 4 at 1.0 (n=8). The primary endpoint for the trial will
assess the safety and tolerability of CLS-AX for three months
following the administration of CLS-AX. There is also an ongoing
extension study to follow patients in Cohorts 2, 3 and 4 for three
months after their completion of OASIS.
“We look forward to providing more data on the
potential benefits of combining targeted and compartmentalized
suprachoroidal delivery via our SCS Microinjector® with the broad
pan-VEGF attributes of axitinib,” said Thomas A. Ciulla, M.D., MBA,
Chief Medical Officer and Chief Development Officer. “The
completion of enrollment in OASIS is a critical milestone as we
look forward to our data readout from the full OASIS trial in the
fourth quarter of this year. We are grateful to all our
investigators and patients whose time and commitment made this
first-in-human, suprachoroidal tyrosine kinase inhibitor trial
possible.”
OASIS Phase 1/2a Clinical Trial
Design
OASIS is an open-label, dose-escalation Phase
1/2a trial in wet AMD patients to assess the safety and
tolerability of a single dose of CLS-AX administered by
suprachoroidal injection via Clearside’s SCS Microinjector®.
Eligible patients are those who demonstrate stable visual
acuity following two or more previous injections with an
intravitreal anti-VEGF agent. All enrolled patients undergo
diagnostic imaging at their screening, followed by masked reading
center confirmation of persistent active disease.
Enrolled patients initially receive aflibercept
at the first visit followed by a single dose of CLS-AX at the
second visit one month later. The primary endpoint for the trial
will assess the safety and tolerability of CLS-AX for the three
months following the administration of CLS-AX, and secondary
endpoints will evaluate the pharmacokinetics, visual function,
ocular anatomy, and the need for additional treatment with
intravitreal aflibercept during the three-month period. Additional
information on the Phase 1/2a trial can be found on
https://clinicaltrials.gov (NCT04626128).
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 effects 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 to potentially treat VEGF-driven disorders such as
wet AMD, diabetic macular edema and diabetic retinopathy.
About Neovascular Age-Related Macular
Degeneration (wet 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. 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 AMD, and about 20% have the wet form. 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.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patented, proprietary suprachoroidal
space (SCS®) injection platform offers unprecedented access to the
back of the eye where sight-threatening disease often occurs.
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. The company’s
unique platform is inherently flexible and intended to work with
established and new formulations of medications. Clearside’s
proprietary SCS Microinjector can be used to inject a wide
variety of drug candidates into the SCS. The SCS Microinjector
provides targeted delivery to potentially improve efficacy and
compartmentalization of medication to reduce or eliminate toxic
effects on non-diseased cells. The SCS Microinjector is composed of
a syringe and two 30-gauge hollow microneedles of varying lengths,
each less than 1.2 millimeters, within a custom-designed hub that
optimizes insertion and suprachoroidal administration of drugs.
About Clearside Biomedical
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
proprietary 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 and strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. Clearside’s first product, XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, is commercially available in the U.S. 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 clinical development of
CLS-AX, including the expected timing of data from the OASIS
clinical trial, and the potential benefits of CLS-AX. 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, 2021, filed with the U.S. Securities and
Exchange Commission (SEC) on March 11, 2022, 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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