FDA OKs Eskata for Raised Seborrheic Keratoses

Megan Brooks

December 15, 2017

The US Food and Drug Administration (FDA) has approved a high-concentration hydrogen peroxide topical solution (Eskata, Aclaris Therapeutics) for the treatment of raised seborrheic keratoses (SKs), the company has announced.

SKs are noncancerous skin growths that affect more than 83 million American adults. They tend to increase in size and number with age. The condition is more common than acne, psoriasis, and rosacea combined, the company notes in a news release.

"For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical, noninvasive treatment for raised SKs," Neal Walker, MD, president and CEO of Aclaris, said in the release.

Eskata is a proprietary, 40% (w/w) hydrogen peroxide–based topical solution. It is a targeted treatment applied by a healthcare provider directly to the raised SK using a penlike applicator.

Eskata can "clear raised SKs without cutting, burning or freezing the skin. 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," Stuart D. Shanler, MD, chief scientific officer for Aclaris, said in the release.

The safety and efficacy of Eskata for the treatment of raised SKs were demonstrated in two phase 3 trials in which patients received up to two treatments. "Patients treated with Eskata were more likely to have all four treated SKs completely cleared after two treatments than patients who received placebo," the company said.

Eskata was generally well tolerated. The most common side effects were itching, stinging, crusting, swelling, redness, and scaling at the site of application. Full prescribing information is available online.

"A recent consumer survey by the American Society for Dermatologic Surgery (ASDS) supports the need for an effective treatment of SKs. Eskata provides physicians with the first topical treatment option to satisfy this unmet patient need," ASDS President Lisa Donofrio, MD, said in the release.

Eskata is expected to be available in the spring of 2018.

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