PDUFA Action Date Is October 30, 2021
LAVAL, QC and ALPHARETTA, Ga., June
2, 2021 /PRNewswire/ -- Bausch Health Companies Inc.
(NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb, its leading
global eye health business, along with Clearside Biomedical, Inc.
(Nasdaq: CLSD) ("Clearside"), 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
the resubmitted New Drug Application for XIPERE™1
(triamcinolone acetonide suprachoroidal injectable suspension). FDA
determined that the filing is a Class 2 resubmission and therefore
assigned a Prescription Drug User Fee Act (PDUFA) action date of
October 30, 2021. XIPERE is an
investigational therapy with a proposed indication of treatment of
macular edema associated with uveitis.
"The FDA's filing acceptance for XIPERE is an exciting milestone
for our collaboration with Clearside. If approved by the FDA,
XIPERE would be the first therapy available utilizing the
suprachoroidal space for patients suffering from macular edema
associated with uveitis, which is the leading cause of vision loss
in people with uveitis. With this acceptance, we are one step
closer to providing an important novel treatment option for this
patient population," said Joseph C.
Papa, chairman and CEO, Bausch
Health.
"XIPERE has the potential to advance the care of people
suffering from macular edema with uveitis," said George Lasezkay,
Pharm.D., J.D., president and CEO, Clearside. "If approved, XIPERE
would be our first commercial product and the first approved drug
to be delivered into the suprachoroidal space (SCS®). We
are committed to continuing the important work with Bausch Health
to help bring forward this important potential treatment option for
patients and eye care professionals in the United States."
XIPERE is designed for suprachoroidal administration via
Clearside's patented, proprietary SCS Microinjector®
that offers unprecedented access to the back of the eye where
sight-threatening disease often occurs. The SCS Microinjector
provides targeted delivery to potentially improve efficacy and
compartmentalization of medication. Targeted drug delivery via the
suprachoroidal space may also limit corticosteroid exposure to the
anterior segment with the potential to reduce the risk of
certain adverse events, such as cataracts, intraocular
pressure elevation and exacerbation of glaucoma, that can commonly
arise from other local corticosteroid delivery techniques.
About XIPERE™
XIPERE™ (triamcinolone acetonide suprachoroidal injectable
suspension), formerly known as CLS-TA, is a proprietary suspension
of the corticosteroid triamcinolone acetonide formulated for
administration to the suprachoroidal space that is being
investigated 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. An affiliate of Bausch Health acquired the
exclusive license for the commercialization and development of
XIPERE in the United States and
Canada in October 2019. The Bausch Health affiliate also
has exclusive options for the right to commercialize and develop
XIPERE in the European Union, 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® targeting the suprachoroidal space
(SCS®) 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 http://www.clearsidebio.com/.
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch
Health Companies Inc., is solely focused on helping people see. Its
core businesses include over-the-counter products, dietary
supplements, eye care products, ophthalmic pharmaceuticals, contact
lenses, lens care products, ophthalmic surgical devices and
instruments. Bausch + Lomb develops, manufactures and markets one
of the most comprehensive product portfolios in the industry, which
is available in approximately 100 countries. For more information,
visit www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. For more information, visit
www.bauschhealth.com and connect with us on Twitter and
LinkedIn.
Bausch Health Forward-looking Statements
This news
release may contain forward-looking statements, which may generally
be identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "believes,"
"estimates," "potential," "target," or "continue" and variations or
similar expressions. These statements are based upon the current
expectations and beliefs of management and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include, but are not limited to, the
risks and uncertainties discussed in Bausch Health's most recent
annual report on Form 10-K and detailed from time to time in Bausch
Health's other filings with the U.S. Securities and Exchange
Commission ("SEC") and the Canadian Securities Administrators,
which factors are incorporated herein by reference. They also
include, but are not limited to, risks and uncertainties caused by
or relating to the evolving COVID-19 pandemic, and the fear of that
pandemic and its potential effects, the severity, duration and
future impact of which are highly uncertain and cannot be
predicted, and which may have a material adverse impact on Bausch
Health, including but not limited to its project development
timelines, and costs (which may increase). Readers are cautioned
not to place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Bausch Health undertakes no obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect
actual outcomes, unless required by law.
Clearside Biomedical 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 potential benefits of XIPERE and
Clearside's SCS Microinjector® as well as 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 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.
1 Provisional name
Any product/brand names are trademarks of the respective
owners.
XIPERE and SCS Microinjector are trademarks of
Clearside Biomedical, Inc.
© 2021 Bausch & Lomb Incorporated or its affiliates.
XIP.0017.USA.21
Clearside
Biomedical Media Contacts:
Jenny Kobin
Remy Bernarda ir@clearsidebio.com
(678) 430-8206
|
Bausch Health
Investor Contact: Arthur
Shannon arthur.shannon@bauschhealth.com
(514) 865-3855 (877) 281-6642
(toll free)
Bausch Health Media
Contact: Lainie
Keller lainie.keller@bauschhealth.com
(908) 927-1198
|
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SOURCE Bausch Health Companies Inc.