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 keratosis, which are noncancerous skin growths.
Aclaris Therapeutics, Inc. a dermatologist-led biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses, or SKs. SKs are non-cancerous skin growths that affect more than 83 million American adults and can be an aesthetic skin concern. SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.
FDA approval of Eskata is based on 2 pivotal phase 3 trials that showed safety & efficacy of eskata for treatment of raised sks .In both trials, patients received up to 2 treatments of the hydrogen peroxide treatment, with one at initiation and the second at week 3. Patients treated with the solution were reportedly more likely to be completely cleared of SKs after 2 treatments than a placebo treatment population.
Though the solution was generally well-tolerated in the patient population, patients reported common adverse effects such as itching, stinging, crusting, swelling, redness, and scaling at the application site.
Aclaris plans to price the drug, Eskata, at the higher end of a $75 to $125 range, Chief Executive Neal Walker said in an interview last month. A price had not yet been decided, he added.
One unit of Eskata would treat six to seven lesions on average, Walker said.
Seborrheic keratoses are harmless, non-cancerous skin growths that affect more than 83 million American adults, according to Aclaris.
Current therapies for treating such skin lesions include cryosurgery, burning, cutting or scraping — all generally painful options that may also cause pigmentation and infection.
Eskata is expected to be commercially available in the spring of 2018.