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FDA approves Aclaris' treatment for a common skin condition

Malvern biotech Aclaris Therapeutics gets FDA approval for its drug to treat a common skin condition that affects over 83 million Americans.

A Malvern biotechnology company, Aclaris Therapeutics, said Friday that its drug to treat a common skin condition called seborrheic keratoses was approved by the U.S. Food and Drug Administration.

The treatment, called Eskata, is the first topical medicine for a type of noncancerous skin growth that affects more than 83 million American adults, and represents Aclaris' first product.

The hydrogen peroxide solution, which is administered in a pen-type applicator in a physician's office, dissolves the growths.

Current treatments are cryosurgery or freezing, burning, cutting, or scraping the growths off, all more invasive and potentially painful options, the company said.

Eskata is expected to be available to dermatologists and healthcare providers in April or May for $100 to $125 per application. The consumer would pay more. "We have not settled on the exact price," said Neal Walker, a dermatologist and Aclaris president and CEO.

The condition is more prevalent than acne, psoriasis and rosacea combined, the company said. The growths often appear on the face, chest, shoulders, or back and have a waxy, scaly, slightly elevated appearance that can vary in color from light tan to dark brown or black.

"They are completely benign, but patients don't like them because they are discolored and have a three-dimensional component and so they seek removal because of the appearance," Walker said.

Health insurance will not cover the treatment. Most growths do not require removal unless a biopsy is needed, the growth has become inflamed, or a patient desires treatment for cosmetic reasons, the company said.

Aclaris, which has 100 employees and plans to hire a sales force of 50, is developing dermatology treatments that are in mid-stage studies for common warts, hair loss, and Vitiligo, which is skin pigment loss.

Walker was president and CEO of another company focused on dermatology, Vicept Therapeutics in Malvern, which was acquired by Allergan Inc. for $275 million in 2011. Vicept had a topical treatment for rosacea.

"For the first time, with the approval of Eskata, patients will have access to an FDA-approved topical,  non-invasive treatment for raised SKs," Walker said.

Aclaris shares closed down 1.98 percent, or 49 cents, to $24.23.