US Food and Drug Administration has accepted the supplemental New Drug Application submitted by Biofrontera for its photodynamic therapy product Ameluz, used with the RhodoLED red-light lamp system, for the treatment of superficial basal cell carcinoma. The regulator reported no filing deficiencies and assigned a Prescription Drug User Fee Act target action date of September 28, 2026.

If approved, the expanded indication would extend the clinical reach of the Ameluz photodynamic therapy platform beyond its current authorization for actinic keratosis. The therapy combines a nanoemulsion topical formulation with red-light illumination engineered to achieve deeper tissue penetration than shorter light wavelengths, supporting treatment of lesions that extend into lower skin layers.

Superficial basal cell carcinoma represents a significant segment of skin cancer cases. Basal cell carcinoma is the most frequently diagnosed cancer in the United States, with an estimated 3.6 million cases annually, and roughly 10 to 25 percent classified as superficial. Many current treatment approaches rely on surgical or destructive methods, which may not suit all patients.

Company leadership said the regulatory milestone reflects continued investment in expanding the photodynamic therapy platform and strengthening its clinical utility. Acceptance of the filing signals regulatory confidence in the supporting data package and advances the product toward a potential new dermatology indication addressing unmet treatment needs.

Approval would position the therapy as a non-invasive alternative aligned with real-world dermatology practice and could significantly broaden the commercial opportunity for the platform. Biofrontera believes the indication would reinforce its standing in medical dermatology while supporting growth of its drug-device manufacturing ecosystem.

The company currently markets the Ameluz and RhodoLED combination for photodynamic treatment of actinic keratosis and continues to pursue additional clinical programs targeting non-melanoma skin cancers and other dermatologic conditions.