Clearside Biomedical Announces CLS-AX (axitinib injectable suspension) Presentation Delivered at Angiogenesis, Exudation, and...
February 16 2021 - 7:05AM
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 David M. Brown, M.D. delivered a
presentation entitled, “Axitinib: A Novel TKI Delivered by
Suprachoroidal Injection for AMD” at the virtual Angiogenesis,
Exudation, and Degeneration 2021 program hosted by the University
of Miami Health System Bascom Palmer Eye Institute on February 12
& 13, 2021.
Dr. Brown’s presentation highlighted several of
the key attributes of axitinib and Clearside’s suprachoroidal
delivery of the agent, including the ease of administration as
demonstrated in a video of a clinical trial patient undergoing the
office-based suprachoroidal delivery procedure. In preclinical
studies, axitinib showed intrinsic high potency, pan-VEGF
inhibition through receptor blockade versus focused VEGF-A
inhibition seen in currently marketed anti-VEGF treatments.
Axitinib is a highly potent tyrosine kinase inhibitor (TKI) that
has been observed preclinically to be greater than ten times more
potent than other TKIs, and inhibits and regresses
angiogenesis.
Suprachoroidal delivery of Clearside’s
proprietary, injectable suspension of axitinib, known as CLS-AX,
has produced up to eleven times higher drug levels in affected
tissues than intravitreal administration of axitinib in preclinical
models. This compartmentalized delivery to affected posterior
tissues may minimize treatment related adverse events, such as
vitreous floaters and corneal and anterior segment exposure. With
the prolonged duration observed in pharmacokinetic studies, this
targeted treatment approach also has the potential to reduce
treatment burden for patients.
“We appreciate Dr. Brown’s thorough presentation
which highlighted the potential of axitinib and CLS-AX to improve
the treatment landscape for the millions of patients suffering from
wet AMD,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer
and Chief Development Officer. “By combining the high potency and
pan-VEGF attributes of axitinib with our proprietary CLS-AX
formulation and delivery via our SCS Microinjector®, we believe we
can achieve clinical adoption of this technique by the retina
community and improve the overall patient experience with a longer
lasting treatment that may reduce or eliminate the challenging side
effects seen with other agents. Our Phase 1/2a OASIS clinical trial
in wet AMD is an ongoing US-based, multi center, open-label,
dose-escalation, safety and tolerability study. We expect to report
initial safety data from the first OASIS cohort mid-year 2021.”
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. Clearside is developing CLS-AX as a long-acting
therapy for the treatment of wet AMD. CLS-AX is currently being
investigated in an ongoing US-based, multi-center, open-label,
dose-escalation, Phase 1/2a, safety and tolerability study,
entitled OASIS, in wet AMD patients, and additional information can
be found on https://clinicaltrials.gov (NCT04626128).
About Clearside’s SCS
Microinjector®
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. 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 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. The Company’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 clinical development,
including the timing of safety data from the OASIS clinical trial,
and the potential benefits, of CLS-AX and therapies 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, 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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