The FDA has accepted the filing of a supplemental new drug application (sNDA) seeking the approval of aminolevulinic acid HCL 10% topical gel (Ameluz) for use in combination with a RhodoLED red light lamp series for the treatment of patients with superficial basal cell carcinoma (BCC).1
No filing deficiencies were identified by the FDA, which assigned a Prescription Drug User Fee Act target action date of September 28, 2026. If the regimen is approved, it would be the first photosensitizer indicated for the treatment of patients with superficial BCC in the US and the second indication for aminolevulinic acid, which is currently approved for the treatment of patients with mild to moderate actinic keratosis on the face and scalp.1,2
Aminolevulinic Acid: A Potential First-in-Class Option for Superficial BCC
- FDA has accepted Biofrontera’s sNDA for aminolevulinic acid HCL 10% topical gel (Ameluz) plus the RhodoLED red light lamp series in patients with superficial basal cell carcinoma.
- A PDUFA date was set for September 28, 2026, with no filing deficiencies identified.
- Photodynamic therapy may address an unmet need in a common disease setting, as superficial BCC accounts for an estimated 10% to 25% of cases among approximately 3.6 million BCC diagnoses in the US each year.
What does the developer say about the FDA’s decision?
“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 Ameluz and reinforce photodynamic therapy as a versatile platform in dermatology,” Hermann Luebbert, PhD, CEO of Biofrontera, stated in a news release.1 “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.”
How does Biofrontera’s photodynamic therapy work?
The combination of nanoemulsion technology with red light illumination allows for deeper penetration into tissue than the shorter wavelengths from green and blue light.1
What unmet need would a potential FDA approval fill?
BCC is the most prevalent cancer in the US, with an annual incidence rate of 3.6 million cases. Approximately 10% to 25% of these diagnoses are characterized as superficial for which surgery or destructive approaches represent primary treatment.1
What data support the use of aminolevulinic acid in superficial BCC?
A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group trial (NCT03573401) was designed to compare photodynamic therapy with aminolevulinic acid HCL 10% gel vs photodynamic therapy with vehicle control for the treatment of patients with superficial BCC.3
Eligible patients had at least 1 naive superficial BCC and received 1 or 2 cycles of photodynamic therapy followed by clinical and histological assessment 12 weeks after the start of the last cycle of therapy. Patients were excluded if they had Gorlin syndrome, xeroderma pigmentosum, photodermatoses, porphyria, hypersensitivity to porphyrins or any element of the 10% topical gel, or significant medical conditions that might affect study procedures or interpretation of the data.
The primary efficacy end point was the composite clinical and histological clearance of the main target lesions 12 weeks after the start of the last treatment cycle. The key secondary efficacy end points included resolution of the main target lesions according to clinical or histological assessment, complete clinical clearance, and complete clearance.
A total of 187 patients were randomly assigned to treatment with the topical gel (n = 145) or the vehicle control (n = 42). The results indicated that the composite clinical and histological clearance rates were 65.5% and 4.8% with the topical gel and vehicle control, respectively (P < .0001). The histological clearance rate was 75.9% with the topical gel vs 19.0% with the vehicle control (P < .0001). The clinical clearance rates were 83.4% and 21.4% with the topical gel and vehicle control, respectively (P < .0001).
After the last treatment cycle, 82.1% of patients who received the topical gel and 21.4% of those who received the vehicle control experienced complete clinical clearance (P < .0001). Additionally, the clinical lesion clearance rate was 82.6% with the topical gel vs 21.6% with the vehicle control.
The esthetic outcome of the treatment was rated as very good or good by patients in 88.1% of cases with the topical gel vs 74.0% of cases with the vehicle control. With respect to safety, no previously unknown adverse effects (AEs) occurred. The most common AEs that occurred in the topical gel arm included application site pain (95.2%), erythema (69.0%), pruritus (50.3%), edema (29.0%), paresthesia (24.1%), site scab (20.7%), and site exfoliation (17.2%).
References
- 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 11, 2026. https://investors.biofrontera-us.com/full-news/?qm-storyId=5387383170976717
- Ameluz. Prescribing information. Biofrontera Inc; 2024. Accessed February 11, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208081s028lbl.pdf
- 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
