Press Release

ESKATA is the First and Only FDA-Approved Topical Treatment for Raised Seborrheic Keratoses

WAYNE, Pa., Oct. 01, 2018 (GLOBE NEWSWIRE) -- 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 Facebookpage; 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
484-329-2140
mtung@aclaristx.com

Media Contact
Sara Baker
Marina Maher Communications
212-485-6836
sbaker@hellommc.com

Source: Aclaris Therapeutics, Inc.