FDA approves Eskata for raised seborrheic keratoses

The FDA has approved a topical, high-concentration hydrogen peroxide solution for raised seborrheic keratoses, according to a company press release.

Eskata (Aclaris Therapeutics) is an in-office treatment administered directly to raised seborrheic keratoses — noncancerous skin growths that often increase in size and number as patients age — using a pen-like applicator. An announcement from Aclaris Therapeutics stated that the growths affect more than 83 million patients in the U.S.

“We are proud to offer Eskata to dermatologists and their patients as a treatment that can clear raised [seborrheic keratoses] without cutting, burning or freezing the skin. As a clinician, I saw first-hand that patients preferred non-invasive treatments,” Stuart D. Shanler, MD, chief scientific officer of Aclaris, said in the press release. “We believe Eskata may appeal to patients who are bothered by the appearance of their raised SKs — especially in highly visible areas such as the face and neck — and that patients are looking for a treatment that is safe and effective.”

The FDA based its approval of Eskata on two phase 3 trials in which patients received the treatment once at baseline and again at 3 weeks. Those who received Eskata were more likely to experience clearing of their seborrheic keratoses compared with patients who received a placebo, according to Aclaris.

The company also reported that the treatment was well tolerated. The most common side effects were swelling, stinging, itching, crusting, redness and scaling at the site of application.

Eskata will be commercially available as a self-pay aesthetic treatment beginning in the spring of 2018.