Clearside Biomedical Expands Patent Portfolio in the U.S. and Europe
August 26 2020 - 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 the recent issuance of three additional
patents in the United States and Europe.
The United States Patent and Trademark Office
(USPTO) recently granted patent number 10,722,396 to
Clearside. This patent covers Clearside’s SCS Microinjector®
for the suprachoroidal administration of axitinib (CLS-AX) and
expires in 2034.
The European Patent Office (EPO) issued two
patents in the largest European markets. Patent number 2,563,429
expires in 2031 and covers a device for the suprachoroidal
administration of any therapeutic agent. Patent number
2,916,827 expires in 2033 and covers the use of XIPERE™
(triamcinolone acetonide suprachoroidal injectable suspension) and
the treatment of uveitis and other posterior ocular diseases with
triamcinolone acetonide.
Clearside’s 21 granted U.S. patents and its 20
granted European patents provide extensive coverage of the SCS
Microinjector device, the use of the device, administration of any
drug into the suprachoroidal space by injection, as well as
specific product candidates.
“Clearside is the market leader in
suprachoroidal delivery, and the issuance of these patents in two
of the largest world markets significantly strengthens the IP
portfolio governing our proprietary SCS Microinjector and our
product candidates,” said George Lasezkay, Pharm.D., J.D.,
President and Chief Executive Officer. “We are committed to
broadening our global patent estate as we continue to expand our
internal pipeline and increase patient access to innovative
therapies. We look forward to achieving additional milestones by
the end of 2020 as we and our partners expect to have three product
candidates delivered via our SCS Microinjector in four clinical
trials.”
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. The company’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 for the treatment of
macular edema associated with 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., has the exclusive license for the commercialization and
development of XIPERE in the United States and Canada and an
exclusive option for 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. 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 XIPERE, the potential
benefits of CLS-AX and the SCS Microinjector, the anticipated
timing of clinical trials conducted by Clearside’s partners and the
expected achievement of certain milestones. 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 June 30, 2020
filed with the SEC on August 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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