BFRI Biofrontera

Ameluz · NCT05080764 registry update

primary_outcomes: ['Relative change in the number of inflammatory lesions (relative change from baseline) 8 weeks after the last PDT as assessed by investigator.', 'Treatment success defined by a minimum improvement of the modified investigator global assessment (mIGA) score by at least 2 assessed 8 weeks after the last PDT and resulting in an mIGA score of 0 (clear) or 1 (almost clear).'] → ['Relative Change in the Number of Inflammatory Lesions (Relative Change From Baseline) 8 Weeks After the Last PDT as Assessed by Investigator.', 'Treatment Success Defined by a Minimum Improvement of the Modified Investigator Global Assessment (mIGA) Score by at Least 2 Assessed 8 Weeks After the Last PDT and Resulting in an mIGA Score of 0 (Clear) or 1 (Almost Clear).']

Biofrontera: FDA approves Ameluz for superficial basal cell carcinoma

FDA approved the sNDA for Ameluz plus BF-RhodoLED red-light PDT for superficial basal cell carcinoma in adults. This makes Ameluz the first and only PDT approved in the US for a skin cancer and the only topical PDT indicated for both actinic keratosis and a skin cancer. The label expansion uses the same product and device already marketed for AK, enabling immediate commercial use.

Biofrontera: FDA sets Sep 28, 2026 PDUFA for Ameluz sNDA in sBCC

FDA accepted the sNDA for Ameluz PDT in superficial basal cell carcinoma and assigned a PDUFA target action date of September 28, 2026. This establishes a near-term regulatory decision point that could expand the approved indications for the Ameluz PDT platform.

Biofrontera: FDA accepts sNDA for Ameluz PDT in sBCC; PDUFA Sept 2026

The press release states that FDA completed its filing review and accepted the sNDA for Ameluz PDT in superficial basal cell carcinoma. This acceptance sets a PDUFA target action date of September 2026, advancing the regulatory path for this new indication.

Biofrontera reports positive Phase 3 topline for Ameluz PDT in AK on extremities, neck, trunk

Phase 3 trial met primary endpoint of subject complete clearance with highly significant superiority over vehicle (p<0.0003). Biofrontera plans to submit sNDA to FDA in Q3 2026 to expand Ameluz label beyond face and scalp.