ESKATA™ is the First and Only
FDA-Approved Topical, Non-invasive Treatment for Raised
SKs; Management to Hold Conference Call at
8:00 AM ET Today
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) has approved ESKATA™ (hydrogen peroxide)
topical solution, 40% (w/w) for the treatment of raised seborrheic
keratoses, or SKs. SKs are non-cancerous skin growths that affect
more than 83 million American adults and can be an aesthetic skin
concern. SKs tend to increase in size and number with age. The
condition is more prevalent than acne, psoriasis and rosacea
combined.
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“This achievement delivers on Aclaris’ commitment to bringing
innovative therapies to market that address significant unmet needs
in dermatology,” said Dr. Neal Walker, President and Chief
Executive Officer of Aclaris. “For the first time, with the
approval of ESKATA, patients will have access to an FDA-approved
topical, non-invasive treatment for raised SKs.”
ESKATA is a proprietary, high-concentration hydrogen
peroxide-based topical solution designed for in-office application
by a healthcare provider. It is a targeted treatment applied
directly to the raised SK using a pen-like applicator.
“We are proud to offer ESKATA to dermatologists and their
patients as a treatment that can clear raised SKs without cutting,
burning or freezing the skin. As a clinician, I saw first-hand that
patients preferred non-invasive treatments,” said Stuart D.
Shanler, M.D., Chief Scientific Officer of Aclaris. “We believe
ESKATA may appeal to patients who are bothered by the appearance of
their raised SKs — especially in highly visible areas such as the
face and neck — and that patients are looking for a treatment that
is safe and effective.”
“Many of my patients begin to notice SKs around age 40 and feel
self-conscious about them,” said Anne M. Chapas, M.D., FAAD,
Founder and Medical Director of Union Square Dermatology; Clinical
Instructor of Dermatology, Mount Sinai Medical Center, New York;
and a consultant for Aclaris. “With the approval of ESKATA, I am
pleased to be able to offer my patients a topical treatment option
that is well tolerated and can clear raised SKs with a low risk of
scarring.”
The FDA approval of ESKATA is based on two pivotal Phase 3
trials that demonstrated the safety and efficacy of ESKATA for the
treatment of raised SKs. In these trials, patients received up to
two treatments with ESKATA, with one at treatment initiation and a
second at week three. Patients treated with ESKATA were more likely
to have all four treated SKs completely cleared after two
treatments than patients who received placebo. Treatment with
ESKATA was generally well tolerated, with the most common side
effects being itching, stinging, crusting, swelling, redness
and scaling at the site of application.
It is important to see a healthcare provider with expertise in
diagnosing skin conditions to confirm the diagnosis of SKs and
determine whether ESKATA is an appropriate treatment.
“A recent consumer survey by the American Society for
Dermatologic Surgery (ASDS) supports the need for an effective
treatment of SKs,” said Lisa Donofrio, M.D., ASDS President.
“ESKATA provides physicians with the first topical treatment option
to satisfy this unmet patient need.”
ESKATA will be offered to patients as a self-pay aesthetic
treatment and is expected to be commercially available in the
spring of 2018. Visit www.ESKATA.com for more information and to
view the full Prescribing Information. In addition, Aclaris has
submitted a Marketing Authorization Application (MAA) for ESKATA
for the treatment of SKs in select countries in the European
Union.
Management will conduct a conference call at 8:00 AM
ET today to discuss the approval of ESKATA. A live webcast of
the event can be accessed on the Events and Presentations page on
the Investors section of the Aclaris website
at www.aclaristx.com/events-and-webcasts. A replay of the
webcast will be archived on the Aclaris website following the
event.
To participate on the live call, please dial 844-776-7782
(domestic) or 661-378-9535 (international), and
reference conference ID 8793369 prior to the start of the
call.
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 the 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 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.
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 Malvern, Pennsylvania and more information can be found
by visiting the Aclaris website at
www.aclaristx.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 Aclaris’ current beliefs and
expectations. These forward-looking statements include expectations
regarding the commercial availability of ESKATA in the spring of
2018 and the expected market opportunity for ESKATA. 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 Aclaris’ reliance on third parties
over which it may not always have full control and other risks and
uncertainties that are described in the Risk Factors section of
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 U.S.
Securities and Exchange Commission 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.comMedia Contact Laura Morgan TogoRun 347-342-8496
L.Morgan@togorun.com
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