FDA accepts new drug application for topical treatment of seborrheic keratosis

Aclaris Therapeutics announced that the FDA has accepted its new drug application for A-101 40% topical solution for potential treatment of seborrheic keratosis.

A-101 40% topical solution is a propriety, high-concentration hydrogen formulation for the treatment of seborrheic keratosis. If approved, it would be the first FDA-approved topical medication for treating the common skin condition, according to a news release from Aclaris.

The Prescription Drug User Fee Act target action date for completion of the FDA’s review is Dec. 24.

The biotechnology company reported that seborrheic keratosis affects more than 83 million Americans; however, fewer than 10% of people with the condition receive treatment, though it is frequently diagnosed by dermatologists.

A-101 40% topical solution is being developed as a noninvasive, in-office treatment to be administered by physicians or other licensed health care professionals.

Patients treated with A-101 40% in clinical trials achieve statistically and clinically significant improvement in clearing of seborrheic keratosis lesion compared with placebo treatment, with adverse event profiles similar between the two treatments, Aclaris reported.

The topical solution penetrates the seborrheic keratosis lesion and causes oxidative damage, which can result in sloughing of the seborrheic keratosis cells, according to the release.

Reference: www.aclaristx.com