Clearside Biomedical Receives Notification of FDA Acceptance of NDA Filing for XIPERE™ (triamcinolone acetonide ophthalmic ...
February 20 2019 - 7:05AM
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing treatments that restore and
preserve vision for people with serious eye diseases, announced
today that it received notification from the U.S. Food and Drug
Administration (FDA) that the Agency has accepted for review the
New Drug Application (NDA) for XIPERE (triamcinolone acetonide
ophthalmic suspension) for Suprachoroidal Injection for the
treatment of macular edema associated with uveitis. The FDA has
determined that the application is sufficiently complete to permit
a substantive review.
The PDUFA (Prescription Drug User Fee Act) goal
date has been assigned for October 19, 2019. This date reflects a
standard review period and is consistent with management’s
expectations for the 505(b)(2) filing.
“We are delighted with this positive news on our
XIPERE NDA. If XIPERE is approved, Clearside will have the first
therapy indicated for patients suffering from macular edema
associated with uveitis,” said Daniel H. White, President and Chief
Executive Officer. “Macular edema is the leading cause of vision
loss, and even blindness, in uveitis patients, and we are now one
step closer to treating this underserved patient population. Over
the last several months, our team has worked diligently to reach
this milestone and we are now preparing to launch the product if
approved.”
The NDA filing is supported by data from the
Phase 3, PEACHTREE clinical trial that demonstrated significant and
clinically meaningful improvement in vision for patients with
macular edema associated with non-infectious uveitis, and that
improvement was achieved across all anatomical locations of
uveitis. Also, in patients with active inflammation at baseline,
resolution was achieved in more than two-thirds of those treated
with XIPERE across three commonly used measures of inflammation:
vitreous haze, anterior chamber cells and anterior chamber
flare.
About PEACHTREE
PEACHTREE, a randomized, masked, sham-controlled
Phase 3 trial, enrolled 160 patients with macular edema associated
with non-infectious uveitis, and compared XIPERE dosed every 12
weeks to sham control. The PEACHTREE trial met its primary
endpoint, with 47% of patients in the XIPERE arm gaining at least
15 letters in best corrected visual acuity from baseline at week
24, compared to 16% of patients in the sham control arm
(p<0.001), using standardized Early Treatment of Diabetic
Retinopathy Study (ETDRS) visual acuity testing. All key secondary
and additional endpoints of the PEACHTREE trial were also
achieved.
About Uveitis and Macular
Edema
Uveitis is a set of ocular inflammatory
conditions and is one of the leading causes of vision loss,
affecting approximately 350,000 patients in the United
States and more than one million worldwide. Approximately
one-third of these patients develop uveitic macular edema, a
build-up of fluid in the macula, the area of the retina responsible
for sharp, straight-ahead vision. Macular edema is the leading
cause of vision loss and blindness in uveitis patients and can
occur from uveitis affecting any anatomic location - anterior,
intermediate, posterior or pan. The uveitis market is expected to
grow by 2024 to nearly $550 million in the United
States and over $1 billion globally.
About XIPERE
XIPERE (triamcinolone acetonide ophthalmic
suspension) for Suprachoroidal Injection formerly known as CLS-TA,
is a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the back of the eye via
suprachoroidal injection 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, thus potentially
providing advantageous and sustained efficacy with a favorable
safety profile.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing treatments that
restore and preserve vision for people with serious eye diseases.
Clearside’s proprietary suprachoroidal treatment approach offers
unprecedented access to the back of the eye where sight-threatening
disease often occurs. The company’s unique platform for eye disease
treatments is inherently flexible and intended to work with
established medicines, new formulations of medicines, as well as
future innovations such as gene therapy. Clearside is headquartered
in Alpharetta, GA. For more information, please visit
http://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 expectations regarding the clinical development
of Clearside’s product candidates, the potential attributes and
benefits of Clearside’s product candidates, and the potential
approval and commercialization of XIPERE in the United States.
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, and other risks and
uncertainties that are described in Clearside’s Annual Report on
Form 10-K for the year ended December 31, 2017, filed with
the U.S. Securities and Exchange Commission
(“SEC”) on March 16, 2018, Clearside’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2018, filed with
the SEC on November 8, 2018,, 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 (919)
423-4799Remy Bernarda (415) 203-6386ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
Clearside Biomedical (NASDAQ:CLSD)
Historical Stock Chart
From Jul 2024 to Jul 2024
Clearside Biomedical (NASDAQ:CLSD)
Historical Stock Chart
From Jul 2023 to Jul 2024