Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company committed to identifying, developing, and
commercializing innovative therapies to address significant unmet
needs in aesthetic and medical dermatology, and immunology, today
announced the publication of the two pivotal trials leading to the
FDA approval of ESKATA (hydrogen peroxide) topical solution, 40%
(w/w), for the treatment of raised seborrheic keratoses (SKs) in a
prestigious peer-reviewed dermatology journal, the online Journal
of the American Academy of Dermatology ahead of print.
The article entitled, “Safety and efficacy of
hydrogen peroxide topical solution, 40% (w/w) in patients with
seborrheic keratoses: results from two identical, randomized,
double-blind, placebo-controlled, Phase 3 studies
(A-101-SEBK-301/302),”1 summarized the pivotal results
demonstrating the safety and efficacy of ESKATA in treating raised
seborrheic keratoses after one to two treatments.
ESKATA is the first and only FDA-approved topical
treatment for raised seborrheic keratoses. It is a proprietary,
high-concentration stabilized hydrogen peroxide topical solution
designed for in-office application by a healthcare provider.
“We are extremely pleased to have the results of
these two pivotal Phase 3 SK trials published in such a prestigious
medical journal,” noted Stuart Shanler, M.D., Chief Scientific
Officer of Aclaris Therapeutics, Inc. “The primary and secondary
efficacy endpoints of our Phase 3 trials were complete clearance of
four out of four SKs or three out of four SKs respectively, which
are high regulatory marks to achieve. As such, it is important to
consider the clinical relevance of exploratory endpoints such as
Clear/Near-Clear when analyzing the data in its totality.”
This study was funded by Aclaris Therapeutics, Inc.
The full article is available for download at
https://www.jaad.org/article/S0190-9622(18)30841-7/fulltext and
will appear in a future print edition of the Journal of the
American Academy of Dermatology.
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 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 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 the commercial use of ESKATA and the
expansion of our intellectual property portfolio covering 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 uncertainties inherent in the conduct
of clinical trials, 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 filed for the year ended
December 31, 2017, Aclaris’ Quarterly Report on Form 10-Q filed
earlier for the quarter ended March 31, 2018 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.
Contacts:Aclaris
ContactMichael Tung, M.D.Senior Vice President Corporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
Media Contact Sara Baker Marina
Maher Communications 212.485.6836 sbaker@hellommc.com
1 Baumann LS, Blauvelt A, Draelos ZD, Kempers SE,
Lupo MP, Schlessinger J, Smith SR, Wilson DC, Bradshaw M, Estes E,
Shanler SD, Safety and efficacy of hydrogen peroxide topical
solution, 40% (w/w) in patients with seborrheic keratoses: results
from two identical, randomized, double-blind, placebo-controlled,
phase 3 studies (A-101-SEBK-301/302), Journal of the American
Academy of Dermatology (2018; published online June 1, 2018), doi:
10.1016/j.jaad.2018.05.044.
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