The Food and Drug Administration has approved Eskata (hydrogen peroxide) topical solution, 40% (w/w), for the treatment of raised seborrheic keratoses, according to Aclaris Therapeutics.
Approval for Eskata is based on results from two phase III clinical trials in which patients with raised SKs received either Eskata or a placebo for two doses, one at baseline and one after 2 weeks. Patients who received Eskata were more likely to have their SKs clear completely, compared with the placebo group.
Eskata is approved only for use in the office of a health care provider and is not for home usage.
The most common adverse events associated with Eskata are itching, stinging, crusting, swelling, redness, and scaling at the application site. Serious skin reactions are possible, and if the medication accidentally enters a patient’s eyes, the patient should flush his or her eyes with water for 15-30 minutes.
“This achievement delivers on Aclaris’ commitment to bringing innovative therapies to market that address significant unmet needs in dermatology. For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, non-invasive treatment for raised SKs,” Dr. Neal Walker, president and chief executive officer of Aclaris, said in written statement.