ESKATA™ received FDA approval for the
treatment of raised seborrheic keratoses (SKs) in December
2017
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company, today announced that data will be
presented from two Phase 3 clinical trials for ESKATA™ for the
treatment of raised seborrheic keratoses (SKs). For the first time,
detailed findings from SEBK-302 and SEBK-303 will be presented to
attendees at the 2018 American Academy of Dermatology (AAD) Annual
Meeting taking place February 16-20 in San Diego, California.
ESKATA, formerly known as A-101 40% topical solution, is the
first and only FDA-approved topical, non-invasive treatment for
raised seborrheic keratoses.
“These data highlight our robust clinical development program
for ESKATA in which over 700 patients received treatment
constituting the largest body of empirical research performed with
respect to any potential raised SK treatment,” said Dr. Neal
Walker, President and Chief Executive Officer of Aclaris. “We look
forward to bringing ESKATA to market and into the hands of
dermatologists seeking a treatment option for their patients that
can clear raised SKs with a low risk of scarring (3% of
patients).”
The scheduled time and location of the data presentation, as
well as titles of posters on display, are as follows:
Open-Label Safety Trial SEBK-303
Poster Title: Open-Label Study of A-101, a 40% Hydrogen
Peroxide Topical Solution, in Patients with Seborrheic Keratosis
(Poster# 6660)Oral Presentation: Friday, February 16 at 9:10
a.m. - 9:15 a.m. Pacific Standard TimeLocation: Poster
Presentation Center, The Connection, Hall A, San Diego Convention
CenterPresentation Title: Open-Label Study of A-101, a 40% Hydrogen
Peroxide Topical Solution, in Patients with Seborrheic
KeratosisPresenting Author: William Phillip Werschler, M.D.,
FAAD, FACS Pivotal Phase 3 Trial
SEBK-302
Poster Title: Safety and Efficacy of A-101, a 40% Hydrogen
Peroxide Topical Solution in Adults With Seborrheic Keratosis:
Results from One of Two Identical Randomized, Double-Blind,
Vehicle-Controlled Phase 3 Studies (Poster# 7454)No Oral
Presentation
Important Safety Information
ESKATA™ (hydrogen peroxide) topical
solution, 40% (w/w) is for use as an in-office treatment. ESKATA is
applied by your healthcare provider and is not for use at
home.
Serious eye problems can happen if ESKATA gets into your eyes.
If ESKATA accidentally gets into your eyes, your healthcare
provider will tell you to flush them well with water for 15 to 30
minutes.
Skin reactions occurred in and around the treatment area after
application of ESKATA. Some were severe, including breakdown of the
outer layer of the skin (erosion), ulcers, blisters and
scarring.
The most common side effects of ESKATA include itching,
stinging, crusting, swelling, redness and scaling.
Tell your healthcare provider about any side effects that bother
you or do not go away. Tell your healthcare provider right away if
ESKATA gets into your eyes, mouth or nose during application.
Approved Use for ESKATA
ESKATA is a prescription medicine used to treat seborrheic
keratoses that are raised.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Contact Aclaris Therapeutics, Inc.
at 1-833-ACLARIS or 1-833-225-2747 or FDA at 1-800-FDA-1088
or
www.fda.gov/medwatch.
Please see ESKATA Full Prescribing Information and Patient
Information at www.ESKATA.com.
About Aclaris
Therapeutics, Inc. Aclaris Therapeutics, Inc. is a
dermatologist-led biopharmaceutical company committed to
identifying, developing and commercializing innovative therapies to
address significant unmet needs in aesthetic and medical
dermatology and immunodermatology. The Company is focused on market
segments with no FDA-approved medications or where treatment
gaps exist. Aclaris is based in Wayne, Pennsylvania and
more information about the company can be found by visiting the
Aclaris website at www.aclaristx.com.
About ESKATA™ ESKATA is the first and only
FDA-approved medication for the treatment of raised seborrheic
keratoses (SKs). Aclaris has submitted a Marketing
Authorization Application (MAA) for ESKATA in select countries in
the European Union.
About Seborrheic Keratoses Seborrheic keratoses
(SKs) are non-cancerous skin growths that affect more than 83
million Americans and are most commonly seen in middle-aged and
older adults. SKs vary in color from flesh-colored to pink, yellow,
gray, tan, brown, or black; can range in size from a millimeter to
a few centimeters wide; and typically have a slightly elevated,
waxy or scaly appearance. The number and size of SKs tends to
increase with advancing age. SKs frequently appear in highly
visible locations, such as the face or neck, but can also appear
anywhere on the body, except the palms, soles and mucous
membranes.
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
Aclaris’ current beliefs and expectations. These
forward-looking statements include expectations regarding Aclaris’
commercialization of ESKATA and its ability to clear raised SKs
with a low risk of scarring. 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 Aclaris’
reliance on third parties over which it may not always have full
control, risks associated with maintaining its intellectual
property portfolio and other risks and uncertainties that are
described in Aclaris’ Annual Report on Form 10-K for the year ended
December 31, 2016, Aclaris’ Quarterly Report on Form 10-Q for the
quarter ended September 30, 2017, and other filings Aclaris
makes with the SEC from time to time. These documents are available
under the “Financial Information” section of the Investors page of
Aclaris’ website at http://www.aclaristx.com. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to Aclaris as of the date of this
release, and Aclaris 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.
Contact: Aclaris Contact Michael Tung, M.D. Vice President /
Investor Relations 484-329-2140 mtung@aclaristx.com
Media Contact Laura Morgan TogoRun 347-342-8496
L.Morgan@togorun.com
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