Clearside Biomedical Announces Resubmission of New Drug Application for XIPERE™ for Treatment of Macular Edema Associated w...
May 03 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 the resubmission of its New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for XIPERETM (triamcinolone acetonide suprachoroidal injectable
suspension) for the treatment of macular edema associated with
uveitis.
Clearside’s resubmission is a full and complete
response to all of the items identified in the Complete Response
Letter (CRL) received from the FDA on October 18, 2019. Clearside
believes this application will be considered a Class 2
resubmission, with a targeted six-month review timeline under the
Prescription Drug User Fee Act.
“The resubmission of the XIPERE NDA is an
important milestone for Clearside,” said George Lasezkay, Pharm.D.,
J.D., President and Chief Executive Officer of Clearside
Biomedical. “As the pioneers in treating back of the eye diseases
through the suprachoroidal space, we believe our extensive clinical
experience with XIPERE shows the potential for a reliable,
non-surgical, office-based method for the treatment of a broad
range of retinal diseases. We appreciate the continued support and
input from our global commercialization partners, Bausch + Lomb and
Arctic Vision, as we look towards the opportunity to improve the
lives of patients suffering from macular edema associated with
uveitis.”
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 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.
(NYSE/TSX: BHC), has the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada and an exclusive option for commercialization and
development of XIPERE in Europe and the United Kingdom, Australia
and New Zealand, and/or South America and Mexico. 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. XIPERE is not yet approved in any
jurisdiction.
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. 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
XIPERE, including whether FDA will accept, and the timing of
potential FDA approval of, the NDA resubmission. 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, 2020, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 15, 2021, 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)
Historical Stock Chart
From Aug 2024 to Sep 2024
Clearside Biomedical (NASDAQ:CLSD)
Historical Stock Chart
From Sep 2023 to Sep 2024