ESKATA is the First and Only FDA-Approved
Topical Treatment for Raised Seborrheic Keratoses
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), 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, today
announced the launch of a direct-to-consumer campaign for ESKATA®
(hydrogen peroxide) topical solution 40%, (w/w), the first and only
FDA-approved topical treatment for raised seborrheic keratoses
(SKs). The direct-to-consumer campaign is designed to educate
patients about the condition and encourage them to find a doctor in
their area to see if they are a candidate for treatment with
ESKATA.
“Seborrheic keratoses are one of the most frequent diagnoses
made by dermatologists, yet the majority of lesions go untreated,”
explains Dr. Neal Walker, President & CEO,
Director, Aclaris Therapeutics, Inc. “While not life
threatening, they can be a significant concern for patients,
especially when they appear on the face, neck or décolletage.
With ESKATA, healthcare professionals now have an FDA-approved
topical treatment designed to treat raised SKs.”
The consumer awareness campaign is based on research that
revealed that SKs can have an impact on our target audience.
The comprehensive campaign includes print advertisements in
highly visible consumer magazines such as Allure, Harper’s BAZAAR,
Marie Claire, New Beauty and Town & Country; online video on
platforms like YouTube; online advertising including banners with
partners including Hearst Magazines Digital Media, SheKnows and
NewBeauty; the launch of a branded Facebook page; engagement with
social media influencers; digital content partnerships; earned
media relations across broadcast, print, online and social media
channels; an updated ESKATA brand website, www.eskata.com; and
brochures available in doctors’ offices.
About ESKATA®ESKATA (hydrogen peroxide) topical
solution, 40% (w/w), is the first and only FDA-approved medication
for the treatment of raised seborrheic keratoses (SKs).
Important Safety Information and Approved
Use
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
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 committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in dermatology, both aesthetic and medical, 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 SKs 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 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, 2017 and other filings Aclaris
makes with the SEC from time to time. These documents are available
under the “Financial Reporting” 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.
Contacts: Aclaris Contact Michael Tung, M.D. Senior Vice
President Corporate Strategy/Investor Relations
484-329-2140mtung@aclaristx.com Media Contact Sara Baker Marina
Maher Communications 212-485-6836 sbaker@hellommc.com
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