FDA approves Biofrontera's sNDA for up to 3 tubes of Ameluz per treatment

Biofrontera Inc.

FDA increased max dosage from 1 to 3 tubes of Ameluz per PDT treatment for actinic keratosis.
Approval supported by two Phase 1 safety studies (116 patients) showing equivalent safety profile.
CEO notes work with Medicare and commercial payers to obtain reimbursement for label update.
AK affects ~58M people in US; ~13M treatments annually; up to 60% of SCCs start as untreated AK.

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