The patent contains 25 claims directed to methods of treating seborrheic keratosis by administering a 40% w/w stabilized hydrogen peroxide composition. Our current marketed product, ESKATA, includes such stabilized hydrogen peroxide. Aclaris’ ESKATA patent estate also includes two other Orange Book listed patents as well as a patent application directed to particular applicators used to administer high-concentration hydrogen peroxide formulations, including 40% and 45% topical solutions of hydrogen peroxide. Internationally, Aclaris has filed applications in
“We are delighted to add another Orange Book listable patent to our robust intellectual property portfolio covering ESKATA. The steadily growing portfolio includes numerous issued patents and pending patent applications in the U.S. and major international markets. We are committed to working on the expansion of our patent protection for ESKATA,” said
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-
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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.
Senior Vice President
Corporate Strategy/Investor Relations
Source: Aclaris Therapeutics, Inc.