Biofrontera submits FDA sNDA seeking Ameluz label expansion for full-body actinic keratoses
BFRI•Biofrontera filed an FDA application to expand Ameluz red-light photodynamic therapy to mild-to-moderate actinic keratoses on areas beyond the face and scalp. Phase 3 data showed complete clearance at 12 weeks in 45.6% of patients, versus 16.7% with vehicle.
1. Application and trial results
The sNDA seeks to extend Ameluz treatment to fields of up to about 240 cm² on the extremities, neck and trunk. Biofrontera also seeks FDA clearance for a revised RhodoLED illumination protocol intended to improve tolerability across all indications.
