Aclaris Therapeutics receives FDA approval for Eskata topical solution
Aclaris Therapeutics (ACRS) announced that the FDA has approved Eskata topical solution, 40% 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.
Seborrheic keratosis is a common skin growth. It may seem worrisome because it can look like a wart, pre-cancerous skin growth (actinic keratosis), or skin cancer. Despite their appearance, seborrheic keratoses are harmless.
Most people get these growths when they are middle aged or older. Because they begin at a later age and can have a wart-like appearance, seborrheic keratoses are often called the “barnacles of aging.” It’s possible to have just one of these growths, but most people develop several. Some growths may have a warty surface while others look like dabs of warm, brown candle wax on the skin.
SKs tend to increase in size and number with age. The condition is more prevalent than acne, psoriasis and rosacea combined.
The FDA approval of Eskata is based on two pivotal Phase 3 trials that demonstrated the safety and efficacy of Eskata for the treatment of raised SKs.
In these trials, patients received up to two treatments with #Eskata, with one at treatment initiation and a second at week three.
Patients treated with Eskata were more likely to have all four treated SKs completely cleared after two treatments than patients who received placebo.
Treatment with Eskata was generally well tolerated, with the most common side effects being itching, stinging, crusting, swelling, redness and scaling at the site of application.
ACRS closed at $24.72.
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