Biofrontera Inc. Reports Positive Phase 2b Results Supporting Continued Development Of Ameluz Photodynamic Therapy For Moderate To Severe Acne Vulgaris

Biofrontera Inc., a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT), announced the results of its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid HCl) topical gel, 10% PDT for treating moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz with a vehicle gel using two incubation times, one hour and three hours, before illumination with the BF-RhodoLED lamp. 

Each participant received an application of either Ameluz or vehicle gel across the full face, followed by incubation and red-light illumination. Up to three PDT sessions were administered at one-month intervals, with patients monitored for two months following their final treatment. The study used co-primary endpoints: one measured the relative reduction in inflammatory lesion counts, while the other required at least a two-grade improvement on the 5-point modified Investigator Global Assessment (mIGA) scale and a rating of “clear” or “almost clear.”

The clinical findings showed that greater improvements in both inflammatory lesion reductions and mIGA scores occurred in the Ameluz three-hour incubation group compared with the vehicle group, identifying this regimen as the most promising for further development. In the per-protocol population for the three-hour incubation, patients treated with Ameluz achieved a 57.97% reduction in inflammatory lesions (n=20) versus 36.51% (n=14) in the vehicle group. For the mIGA co-primary endpoint, 25% of Ameluz-treated participants met the required improvement compared with 21.4% in the vehicle group. Absolute reductions in inflammatory, non-inflammatory, and total lesion counts also favored the Ameluz group, further reinforcing the strength of the three-hour protocol.

The safety and tolerability profile of Ameluz PDT was consistent with the known experience of photodynamic therapy. The most commonly reported treatment-related adverse events were burning sensation and pruritus, generally rated as mild to moderate. Average pain scores during the three-hour incubation sessions were modest, ranging from 3.4 to 3.8 for the Ameluz group and 2.0 to 2.1 for those receiving the vehicle, based on an 11-point scale. Patient feedback was positive, with 85.7% of individuals in the three-hour Ameluz group stating they would choose PDT again, and 71.4% rating their esthetic outcome as “good” or “very good.”

Acne vulgaris remains one of the most prevalent dermatologic conditions in the United States, affecting millions and contributing to permanent scarring and significant psychosocial impact, including reduced confidence and depression. Current treatment options often require long-term daily use of topical agents or systemic therapies such as antibiotics or isotretinoin, which may carry notable safety considerations and are increasingly challenged by antibiotic resistance. PDT offers dermatologists an alternative in-office treatment option that avoids chronic systemic exposure while delivering controlled, physician-supervised therapy with high compliance.

Commenting on the results, Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed enthusiasm about the progress of the clinical program. He noted that the Phase 2b data demonstrate promising reductions across inflammatory, non-inflammatory, and total lesions with Ameluz PDT after three-hour incubation, alongside improvements in mIGA outcomes. He stated that the successful completion of this study moves the company closer to potentially offering an effective and well-tolerated treatment option for patients with moderate to severe acne, while expanding the possible indications for Ameluz and strengthening the company’s dermatology portfolio.

Mitchel P. Goldman, Medical Director of Cosmetic Laser Dermatology, Board Member at Platinum Dermatology Partners, and coordinating investigator for the study, highlighted the significance of these findings. He noted that many acne patients still rely on treatment plans that can be burdensome, and that the potential expansion of Ameluz PDT into acne care represents an encouraging development for both physicians and patients. Biofrontera plans to present the full Phase 2b dataset to the U.S. Food and Drug Administration in the third quarter of 2026 to discuss potential next steps in the development of Ameluz PDT for acne vulgaris.