Approved in the US
Developed by Aclaris Therapeutics, Eskata™ (hydrogen peroxide) is an approved, topical, non-invasive treatment for raised seborrheic keratosis (SK).
Aclaris submitted a new drug application (NDA) for Eskata in February 2017, which was accepted for review by the US Food and Drug Administration (FDA) in May of the same year and approved in December.
Eskata is expected to be launched commercially in the US in around mid-2018.
Aclaris has also submitted a marketing authorisation application (MAA) for Eskata in certain EU countries.
Seborrheic Keratoses causes and symptoms
SKs are non-contagious and non-cancerous skin growths that can occur anywhere on the body. They first appear as small rough bumps but often thicken and grow into a wart-like lump.
SKs are estimated to affect approximately 83 million adults in the US and is more widespread than skin diseases such as acne, psoriasis and rosacea.
Treatments for SKs are often painful or invasive and can lead to scarring or pigmentation.
Eskata’s mechanism of action
Eskata contains a high-concentration hydrogen peroxide formulation as a 40% weight / weight (w / w) topical solution. It can be applied directly to the affected area using a pen-like applicator.
The mechanism of action (MoA) is designed to penetrate the SK lesions and cause oxidative damage so that the cells can be shed.
Clinical trials on Eskata
FDA approval for Eskata™ was based on results obtained from two pivotal Phase III clinical trials named SEBK-301 and SEBK-302. The clinical studies enrolled a total of 937 patients with four target SK lesions across 34 centres in the US.
Out of a total of 937 patients, 467 were administered with Eskata and the remaining 470 were administered placebo. The primary endpoint of both clinical studies was the percentage of patients treated with Eskata, who achieved clearance of all four target lesions.
The studies’ results demonstrated that patients treated with Eskata were either cleared or nearly cleared of all SKs after two treatments, compared with the patients who received a placebo.
In the SEBK-301 study, 4% of the patients administered with Eskata achieved clearance, compared to 7.8% of the patients treated with Eskata in the SEBK-302 study. Patients administered with placebo in both studies did not achieve clearance of all four target SK lesions.
The results also showed that 13.5% of patients treated with Eskata achieved clearance of at least three of the four target SK lesions in the first clinical trial, compared with 23% of patients in the second study.
The overall combined trial results showed that 51.3% of lesions treated with Eskata were either clear or near clear at the completion of the trial, compared to 7.3% lesions in the placebo group. The studies also showed that 65.3% of lesions on the face treated with Eskata were evaluated as clear or near clear, compared with 10.5% of lesions in the placebo group.
Eskata was generally well tolerated in the clinical studies with the most common reactions being itching, crusting, redness and scaling at the site of application.
Marketing commentary on Aclaris Therapeutics
Headquartered at Malvern in Pennsylvania, US, Aclaris Therapeutics is a biopharmaceutical company led by a dermatologist.
It is involved in the identification, development and marketing of innovative therapies in the fields of aesthetic, medical dermatology and immuno-dermatology.
The company has an experienced team capable of developing and marketing FDA-approved medications for dermatologic treatments.