An Aclaris (ACRS -2.2%) advertisement for its Eskata hydrogen peroxide topical solution “makes false or misleading claims” about the product’s risks and efficacy, the Food and Drug Administration says.
The video “fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders… in the case of exposure to the eye and severe skin reactions including scarring,” the FDA says.
Eskata, which has been available for purchase by dermatologists in the U.S. for slightly more than a year, is the first and only FDA-approved topical treatment for raised seborrheic keratoses.
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