“In its role as the reference member state,
Aclaris is seeking a commercial partner or partners to market the medicine as an aesthetic skin treatment in various European countries with the brand name ESKATA in
U.S. Important Patient Safety Information
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 in the U.S.
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-
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.
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 marketing approval of ESKATA in other countries, Aclaris’ regulatory strategy and ex- U.S. business partnerships. 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
Aclaris Therapeutics Contacts
Senior Vice President, Corporate Strategy/Investor Relations
Vice President, Corporate Communications
Business Development Contact
Vice President, Business Development
Source: Aclaris Therapeutics, Inc.