ESKATA™ received FDA approval for the treatment of raised seborrheic keratoses (SKs) in December 2017

WAYNE, Pa., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, today announced that data will be presented from two Phase 3 clinical trials for ESKATA™ for the treatment of raised seborrheic keratoses (SKs). For the first time, detailed findings from SEBK-302 and SEBK-303 will be presented to attendees at the 2018 American Academy of Dermatology (AAD) Annual Meeting taking place February 16-20 in San Diego, California.

ESKATA, formerly known as A-101 40% topical solution, is the first and only FDA-approved topical, non-invasive treatment for raised seborrheic keratoses.

“These data highlight our robust clinical development program for ESKATA in which over 700 patients received treatment constituting the largest body of empirical research performed with respect to any potential raised SK treatment,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “We look forward to bringing ESKATA to market and into the hands of dermatologists seeking a treatment option for their patients that can clear raised SKs with a low risk of scarring (3% of patients).”

The scheduled time and location of the data presentation, as well as titles of posters on display, are as follows:

Open-Label Safety Trial SEBK-303

Poster Title:  Open-Label Study of A-101, a 40% Hydrogen Peroxide Topical Solution, in Patients with Seborrheic Keratosis (Poster# 6660)
Oral Presentation:  Friday, February 16 at 9:10 a.m. - 9:15 a.m. Pacific Standard Time
Location:  Poster Presentation Center, The Connection, Hall A, San Diego Convention Center
Presentation Title: Open-Label Study of A-101, a 40% Hydrogen Peroxide Topical Solution, in Patients with Seborrheic Keratosis
Presenting Author:  William Phillip Werschler, M.D., FAAD, FACS
  
Pivotal Phase 3 Trial SEBK-302

Poster Title: Safety and Efficacy of A-101, a 40% Hydrogen Peroxide Topical Solution in Adults With Seborrheic Keratosis: Results from One of Two Identical Randomized, Double-Blind, Vehicle-Controlled Phase 3 Studies (Poster# 7454)
No Oral Presentation

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 Aclaris Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747 or 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 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 Wayne, Pennsylvania and more information about the company can be found by visiting the Aclaris website at www.aclaristx.com.

About ESKATA™
ESKATA is the first and only FDA-approved medication for the treatment of raised seborrheic keratoses (SKs).  Aclaris has submitted a Marketing Authorization Application (MAA) for ESKATA in select countries in the European Union.

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.

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, 2016, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017,  and other filings Aclaris makes with the SEC 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.com

Media Contact
Laura Morgan
TogoRun
347-342-8496 
L.Morgan@togorun.com