Biofrontera, Inc. is a biopharmaceutical company, which engages in the commercialization of pharmaceutical products. It specializes in the treatment of dermatological conditions, caused primarily by exposure to sunlight that results in sun damage to the skin. The company is focused on the treatment of actinic keratosis and markets a topical antibiotic for treatment of impetigo. Its products include Ameluz and Xepi, its two prescription drugs, and BF-RhodoLED, a lamp used with Ameluz, for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. The company was founded on March 3, 2015 and is headquartered in Woburn, MA.
Biofrontera Inc. has secured FDA approval for a reformulated Ameluz nanoemulsion gel, extending patent protection until 2043 and allowing up to three tubes per treatment, potentially increasing revenue through larger average sales.
Biofrontera's Phase 3 trial of Ameluz-PDT for superficial basal cell carcinoma (sBCC) has reached a crucial milestone with all patients completing the 1-year follow-up.
Ameluz-PDT significantly improved target lesion clearance in superficial basal cell carcinoma (sBCC) compared to placebo-PDT in a phase 3 trial.
Biofrontera's Ameluz-PDT therapy met the primary endpoint, showing 65.5% success in complete clearance of superficial basal cell carcinoma (sBCC) lesions, compared to 4.8% with placebo.
Biofrontera's Ameluz-PDT therapy met the primary endpoint in a Phase III trial for superficial basal cell carcinoma (sBCC), showing significant clinical and histological clearance.
Biofrontera's Ameluz-PDT achieved a 65.5% success rate in complete clearance of sBCC lesions, significantly outperforming placebo at 4.8%.
Biofrontera has locked the database for its Phase 3 trial evaluating Ameluz®-PDT for superficial basal cell carcinoma (sBCC) treatment.
The FDA has approved a supplemental New Drug Application (sNDA) for Biofrontera's Ameluz, allowing up to three tubes per actinic keratosis treatment.
The FDA has approved Biofrontera's supplemental New Drug Application (sNDA) to allow the use of up to three tubes of Ameluz per photodynamic therapy (PDT) treatment.
Biofrontera's Ameluz seeks expanded dosage approval for actinic keratosis treatment, potentially improving convenience for patients and dermatologists.