Biofrontera Submits Ameluz SNDA For Expanded Actinic Keratosis Use

October 08, 2026 — 09:47 am EDT

Written by RTTNews.com for RTTNews

(RTTNews) - On Thursday, Biofrontera Inc. (BFRI) said it has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking to expand the approved use of Ameluz in combination with photodynamic therapy (PDT) for the treatment of actinic keratoses (AKs).

Ameluz (aminolevulinic acid hydrochloride) is a topical drug used in combination with red-light PDT to treat AKs, which are precancerous skin lesions that may progress to squamous cell carcinoma.

The submission is supported by positive Phase 3 results, in which Ameluz met its primary endpoint and demonstrated statistically significant superiority over vehicle gel. A Phase 1 pharmacokinetic study also provided supporting data for the submission.

Biofrontera plans to seek an expanded treatment field of up to 240 square centimeters for AKs on the extremities, neck and trunk, beyond the currently approved face and scalp indication.

BFRI is trading down 3.77% at $0.90.

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Biofrontera Submits Ameluz SNDA For Expanded Actinic Keratosis Use

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