Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body
Biofrontera submitted a supplemental new drug application to the FDA seeking to expand Ameluz red-light photodynamic therapy use for actinic keratoses beyond the face and scalp, to treatment fields of up to approximately 240 cm² on the rest of the body. The submission includes an adjusted illumination protocol.
Why it matters — The application seeks a broader treatment-area label for Ameluz, a development BFRI watchers may follow.