Aclaris Therapeutics announced that the Food and Drug Administration (FDA) has approved Eskata (hydrogen peroxide) topical solution for the treatment of raised seborrheic keratoses.
Eskata is a high-concentration hydrogen peroxide-based topical solution intended for application in office by a healthcare provider. The pen-like applicator allows for a direct treatment application.
The FDA approval was supported by 2 Phase 3 studies that demonstrated the safety and efficacy of Eskata for the treatment of raised seborrheic keratoses. Study patients received up to 2 treatments with Eskata—1 at the start of study and 1 at Week 3.
Those treated with Eskata were more likely to have all 4 treated seborrheic keratoses completely cleared after 2 treatments vs patients who received placebo. Eskata was generally well tolerated; itching, stinging, crusting, swelling, redness, and scaling at the site of application were the most common adverse effects.
Eskata will be available as a 40% (w/w) topical solution in 1.5mL and 2.2mL fill volume applicators in 1-, 3-, and 12-count cartons. It is anticipated to launch in the spring of 2018. Pre-ordering will be possible 2 weeks prior to product launch.
Aclaris therapeutics receives FDA approvals for ESKATA (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses (SKs) [press release]. Malvern, PA: Globe Newswire; December 15, 2017. Accessed December 19, 2017,
This article originally appeared on MPR