Eskata Approved for Raised Seborrheic Keratoses
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 two 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—one at the start of study and one 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.
For more information call (833) 225-2747 or visit Eskata.com.