The FDA has approved aminolevulinic acid hydrochloride (Ameluz), a 10% topical gel, in combination with photodynamic therapy such as the BF-RhodoLED® lamp series for patients with superficial basal cell carcinoma, according to a press release by Biofrontera.1
Currently, the topical gel is the first photodynamic treatment approved by the FDA for the treatment of skin cancer. The approval came from results from a phase 3 trial (NCT03573401) assessing 145 patients receiving photodynamic therapy plus 10% aminolevulinic acid gel compared with 42 patients who received PDT plus a vehicle.2
“FDA approval of [aminolevulinic acid hydrochloride] for superficial basal cell carcinoma is a defining milestone for Biofrontera. [Aminolevulinic acid hydrochloride] is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years of disciplined investment in the clinical development of [aminolevulinic acid hydrochloride], and the latest stage in the ongoing expansion of our PDT platform,” Hermann Luebbert, chief executive officer and chairman of Biofrontera, said in the press release.
Topline data from the trial showed that 66% of patients given the topical gel plus photodynamic therapy achieved a response compared with 5% of patients in the placebo arm. Histological clearance of the main target lesions was noted in 76% vs 19%, while 83% of patients treated with the topical gel had complete clinical clearance of all target lesions vs 21% in the placebo arm.
Overall, the most common adverse effects were application-site reactions. These were consistent with the known safety profile.
“For many patients with superficial basal cell carcinoma—those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred—treatment options have been limited. This FDA approval for [aminolevulinic acid hydrochloride] and the [PDT] gives us a rigorously studied, non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful expansion in the use of this treatment,” M. Shane Chapman, MD, MBA, professor of dermatology and inaugeral chair in the Department of Dermatology, said in the press release.
References
- Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma. News release. Biofrontera. September 14, 2026. Accessed September 14, 2026. https://tinyurl.com/mr35rdk3
- 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
