Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a dermatologist-led
biopharmaceutical company focused on dermatological and
immuno-inflammatory diseases, today announced that it received
approval from the Swedish Medical Products Agency to market ESKATA®
(hydrogen peroxide) cutaneous solution, 685 mg for the treatment in
adults of seborrheic keratoses that are not pedunculated and have
up to a maximum diameter of 15 mm each. Aclaris also has received
approval to market the medicine in the United Kingdom, Iceland,
Belgium, and Finland.
“In its role as the reference member state, Sweden worked with
all concerned member states to establish the approvability of the
medicine,” said Christopher Powala, Chief Regulatory and
Development Officer for Aclaris. “We have submitted marketing
authorization applications in ten additional member states within
the European Economic Area through the decentralized
procedure.”
Aclaris is seeking a commercial partner or partners to market
the medicine as an aesthetic skin treatment in various European
countries with the brand name ESKATA in Finland, Iceland,
Netherlands, Norway, Portugal, Spain, Sweden, Czech Republic,
Belgium and the brand name ESKERIELE® in Austria, France, Germany,
Ireland, Italy, and the United Kingdom.
About ESKATA
In December 2017, ESKATA® (hydrogen peroxide) topical solution,
40% (w/w) received U.S. Food and Drug Administration (FDA) approval
to treat raised seborrheic keratoses, or SKs.
U.S. Important Patient Safety Information
ESKATA can cause serious side effects,
including:
- Eye problems. Eye problems can happen if
ESKATA (hydrogen peroxide) topical solution, 40% (w/w) gets into
your eyes, including: ulcers or small holes in your eyes, scarring,
redness, irritation, eyelid swelling, severe eye pain, and
permanent eye injury, including blindness.
- If ESKATA accidentally gets into your eyes, your
healthcare provider will tell you to flush them well with water for
15 to 30 minutes. Your healthcare provider may send you to
another healthcare provider if needed.
- Local skin reactions. Skin reactions
have happened in and around the treatment area after application of
ESKATA. Severe skin reactions can include: breakdown of the outer
layer of the skin (erosion), ulcers, blisters and scarring. Tell
your healthcare provider if you have any skin reactions during
treatment with ESKATA.
The most common side effects of ESKATA include:
itching, stinging, crusting, swelling, redness and scaling.
Your healthcare provider will not apply another treatment of
ESKATA if your treated area is still irritated from the previous
treatment.
Tell your healthcare provider right away if ESKATA gets into
your eyes, mouth or nose during application. ESKATA is for
topical use on the skin only, and is not for use in your eyes,
mouth or vagina.
These are not all the possible side effects of ESKATA.
Approved Use for ESKATA in the U.S.
ESKATA is a prescription medicine used to treat seborrheic
keratoses that are raised.
ESKATA is for use as an in-office treatment. ESKATA is applied
by your healthcare provider and is not for use at home.
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.
About Seborrheic
Keratoses
Seborrheic keratoses (SKs) are non-cancerous skin growths that
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 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.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led
biopharmaceutical company focused on identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology and immunology. Aclaris’
focus on market segments with no FDA-approved medications or where
treatment gaps exist has resulted in the first FDA-approved
treatment for raised seborrheic keratoses and several clinical
programs to develop medications for the potential treatment of
common warts, alopecia areata, and vitiligo. For additional
information, please visit www.aclaristx.com and follow Aclaris on
LinkedIn.
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 marketing approval of ESKATA in other countries, Aclaris’
regulatory strategy and ex- U.S. business partnerships. 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, 2017, Aclaris’ Quarterly
Report on Form 10-Q for the quarter ended September 30, 2018 and
other filings Aclaris makes with the SEC from time to time. These
documents are available under the "SEC filings" 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.
Aclaris Therapeutics Contacts
Investor ContactMichael Tung, M.D.Senior Vice President,
Corporate Strategy/Investor
Relations484-329-2140mtung@aclaristx.com
Media ContactSheila KennedyVice President, Corporate
Communications484-321-5559media@aclaristx.com
Business Development ContactJeffrey WayneVice President,
Business Development(484) 999-4901jwayne@aclaristx.com
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