Clearside Biomedical Announces U.S. FDA Acceptance of Investigational New Drug Application for CLS-AX (axitinib injectable su...
August 10 2020 - 4:02PM
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 the U.S. Food and Drug
Administration (FDA) has accepted its Investigational New Drug
(IND) application for CLS-AX (axitinib injectable suspension),
enabling initiation of a Phase 1/2a clinical trial of CLS-AX in
neovascular age-related macular degeneration (wet AMD) patients by
the end of 2020.
“The FDA’s acceptance of our IND submission for
CLS-AX is a significant achievement for Clearside and demonstrates
our ability to successful move another internally-developed program
into the clinic,” said George Lasezkay, Pharm.D., J.D., President
and Chief Executive Officer. “As a tyrosine kinase inhibitor (TKI),
axitinib has demonstrated pan-VEGF inhibition in independent
studies and may have the potential to be more efficacious than
current, more narrowly focused VEGF inhibition approaches. In our
internal preclinical studies, CLS-AX delivered through
suprachoroidal injection was well tolerated and showed durability
over several months, providing Clearside the opportunity to
potentially reduce treatment burden and address a primary need for
wet AMD patients. We look forward to initiating clinical work by
the end of 2020.”
The Phase 1/2a clinical trial in wet AMD
patients is expected to be an open-label, dose-escalation study to
assess the safety and tolerability of single doses of CLS-AX
administered through suprachoroidal injection following two or more
prior treatments with an intravitreal anti-VEGF agent.
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 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 timing of initiating
the Phase 1/2a clinical trial for CLS-AX in wet AMD and the
potential benefits of CLS-AX and the 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 filed with the SEC on May 8, 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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