ESKATA™ is the First and Only FDA-Approved Topical Treatment for Raised Seborrheic Keratoses; Aclaris Partnering with McKesson for U.S. Distribution
MALVERN, Pa., May 07, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, today announced that ESKATA™ is now available for purchase by dermatologists in the United States. ESKATA is the first and only FDA-approved topical treatment for raised seborrheic keratoses (SKs) – benign skin growths that may be a cosmetic concern, especially when they appear on the face, neck or chest area.
“With ESKATA, dermatologists may now offer their patients a topical treatment option for raised SKs,” said Brett Fair, Chief Commercial Officer of Aclaris. “Our mission at Aclaris is to identify, develop and commercialize innovative therapies to address unmet needs in aesthetics and medical dermatology and immunology. The introduction of ESKATA – six years in the making – delivers on this goal.”
ESKATA is a proprietary, high-concentration stabilized hydrogen peroxide 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. Typically, two treatments are required and scheduled approximately three weeks apart.
“Though not life threatening, raised SKs can make patients feel self-conscious, yet the majority of these lesions go untreated,” said Marina Peredo, M.D., F.A.A.D, an associate clinical professor of Dermatology at Mount Sinai Hospital in New York and founder of Skinfluence, a dermatology practice on the Upper East Side of Manhattan. “Now, with the introduction of ESKATA, my colleagues and I finally have a topical treatment option.”
Aclaris has partnered with McKesson, a global leader in healthcare supply chain management solutions, to support its salesforce for the distribution of ESKATA.
ESKATA received Food and Drug Administration (FDA) approval on December 14, 2017 and will be offered to physicians as a self-pay treatment for patients. Prescribers may visit www.ESKATA.com for more information, to place an order for ESKATA and to view the full Prescribing Information.
It is important to see a healthcare provider with expertise in diagnosing skin conditions to confirm the diagnosis of raised SKs and determine whether ESKATA is an appropriate treatment.
Important Safety Information and Approved Use
ESKATA can cause serious side effects, including:
- Eye problems. Eye problems can happen if ESKATATM (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 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 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.
About McKesson Corporation
McKesson Corporation, currently ranked 5th on the FORTUNE 500, is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information technology. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by its ICARE shared principles, its employees work every day to innovate and deliver opportunities that make its customers and partners more successful — all for the better health of patients. McKesson has been named the “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.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 Aclaris’ commercialization of ESKATA and its ability to clear raised SKs. 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 Aclaris’ Annual Report on Form 10-K for the year ended December 31, 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.