FDA Accepts Topical Gel sNDA for Superficial Basal Cell Carcinoma

A supplemental new drug application (sNDA) has been accepted by the FDA for aminolevulinic acid hydrochloride (Ameluz) plus RhodoLED red-light lamp series for patients with superficial basal cell carcinoma, according to a press release from Biofrontera.¹

A Prescription Drug User Fee Act date of September 28, 2026, has been set by the FDA. This treatment, if approved, would offer clinicians and patients a non-invasive option that is aligned with real-world practice needs.

“We are proud of the investments we continue to make in this specialty. This milestone represents an important step forward in our strategy to expand the clinical utility of [aminolevulinic acid hydrochloride] and reinforce photodynamic therapy as a versatile platform in dermatology. The FDA’s acknowledgement of no filing deficiencies in our sNDA reflects the strength of the data package and allows us to move forward with confidence toward a potential new indication that addresses a meaningful unmet medical need,” said Hermann Luebbert, PhD, chief executive officer of Biofrontera.

Results from a phase 3 trial (NCT03573401) assessed 145 patients with photodynamic therapy (PDT) plus 10% aminolevulinic acid (ALA) gel vs 42 patients who received PDT plus a vehicle.² Overall, the median age at inclusion was 64 years, 58.3% of patients were male, and 100% were White. The location of the main target lesion included 2.1% on the face/scalp, 52.4% on the neck/trunk, and 45.5% on the extremities.

The primary end point was the composite clinical and histological clearance of main target lesions at the histological or clinical assessment. Secondary end points included clearance of main target lesions, participant complete clinical clearance, and participant complete clearance.

After the last cycle of PDT, the clearance rates of the main target lesions were 83.4% with the gel vs 21.4% with the vehicle (P <.0001). Similar results were also observed for histological clearance, with 75.9% for the gel and 19.0% for the vehicle (P <.0001). Additionally, the composite clinical and histological clearance rates were 65.5% vs 4.8% (P <.0001).

The study found that in the gel group, the clinical and histological clearance was independent of the lesion location, with the neck/trunk being 83.3% vs 72.2%, respectively, and the extremities being 83.1% vs 78.9%, respectively. Of note, the baseline size of main target lesions did affect clearance rates, with clinical clearance of 90.7% at 81 mm² or less, 88.0% at 84 to 160 mm², and 73.1% at 165 mm² or more; histological clearance was 86.0%, 74.0%, and 69.2% at the same values.

After the completion of the first PDT cycle, 57.2% of patients with main target lesions were treated with the gel compared with 14.3% who were given the vehicle and showed complete clinical clearance (P <.0001).

Esthetic outcomes showed that 89.3% of lesions treated with the gel were good or very good compared with 58.0% in the vehicle group. Patients also rated their satisfaction with the esthetic outcomes as very good or good, with 88.1% vs 74.0% between the gel and the vehicle, and 95.0% vs 100.0%, respectively, would choose the treatment again.

The most common treatment emergent adverse effects included application site pain (95.2% vs 28.6%), application site erythema (69.0% vs 35.7%), application site pruritus (50.3% vs 26.2%), application site edema (29.0% vs 11.9%), and application site paresthesia (24.1% vs 11.9%).

References

1. Biofrontera announces FDA filing acceptance of supplemental new drug application for Ameluz® PDT in superficial basal cell carcinoma. News release. Biofrontera. February 11, 2026. Accessed February 12, 2026. https://tinyurl.com/5dh37p8e
2. Schlesinger T, Chapman MS, Tu JH, et al. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025;93(6):1489-1498. doi:10.1016/j.jaad.2025.08.031