Biofrontera has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand the approved use of Ameluz (aminolevulinic acid hydrochloride) gel in photodynamic therapy (PDT) for actinic keratoses (AKs) on areas of the body beyond its currently labeled treatment sites.

The filing, announced by the company and reported by The Dermatology Digest, marks the formal regulatory step in Biofrontera's effort to widen Ameluz PDT from its established field of use to additional anatomical regions — a move that, if approved, would give dermatologists a labeled option for lesions across the body.

What does the submission cover?

An sNDA asks the FDA to modify an already-approved product label rather than to authorize a new drug. In this case, Biofrontera is requesting that Ameluz's indication be extended so the gel, used in combination with photodynamic therapy under red light, can be applied to actinic keratoses on parts of the body outside the sites named in the current approval.

Actinic keratoses are common, sun-induced premalignant lesions of keratinocyte origin. Left untreated, a proportion of AKs can progress to cutaneous squamous cell carcinoma, which is why field therapy approaches such as PDT — treating wide, lesion-dense zones rather than isolated spots — have gained traction in dermatologic practice. A broader body-site label would position Ameluz PDT as an option for patients whose photodamage extends to the trunk and extremities, not just the areas where the product is cleared today.

Why does a wider label matter for dermatologists?

For clinicians, label scope determines how a therapy can be marketed, studied and, in many cases, reimbursed. Off-label use of approved agents is legal and common in dermatology, but an explicit indication for additional body sites changes the evidentiary footing: it anchors the product in trial data the FDA has reviewed for those specific locations and gives prescribers clearer guidance on protocol — application time, occlusion, light dosimetry — across a wider patient population.

A body-wide AK label would also align Ameluz with the clinical reality of field cancerization, in which patients present with diffuse actinic damage across multiple regions. Treating such patients site by site under a narrow label creates friction in scheduling, documentation and payer communication.

What happens next?

The sNDA now sits with the FDA for review. Under standard procedures, the agency will assess the submission for completeness before determining its review pathway and timeline; the company has not publicly specified whether it requested priority review. If the FDA accepts the application and ultimately approves the expanded indication, Ameluz PDT would carry a label covering actinic keratoses across the body, subject to whatever conditions the agency attaches.

Dermatology practices tracking the filing will be watching for the FDA's acceptance decision and, downstream, for the label language that defines which anatomical sites, lesion grades and treatment parameters the expanded approval covers — details that will shape both clinical protocols and reimbursement conversations for field-directed AK therapy.