Biofrontera Advances Light Therapy for Two of Dermatology's Biggest Challenges

WOBURN, MA – January 08, 2026 – Biofrontera Inc. has hit a critical milestone in its quest to expand the use of its light-based treatment, Ameluz, signaling a potential paradigm shift for two of the most common skin disorders in the United States. The biopharmaceutical company announced it has locked the databases for two major clinical studies, one targeting pre-cancerous skin lesions and the other focused on moderate to severe acne.

This procedural step, completed on January 5, 2026, finalizes the data collection phase and paves the way for statistical analysis. The results, expected as early as February, will determine the next steps in bringing Ameluz photodynamic therapy (PDT) to millions of patients suffering from actinic keratosis (AK) on the body and persistent acne vulgaris. The news has already sparked significant investor optimism, with the company's stock (NASDAQ: BFRI) surging over 40% in the past week.

Expanding the Battlefield Against Pre-Cancerous Lesions

Ameluz, a photosensitizing gel activated by a specific red-light lamp, is already an established treatment for mild to moderate actinic keratosis on the face and scalp. These lesions, caused by chronic sun exposure, affect an estimated 58 million Americans and carry the risk of progressing into squamous cell carcinoma, a life-threatening skin cancer. While effective, the current approval limits its use to highly visible but smaller areas.

Biofrontera's now-completed Phase 3 study aims to shatter that limitation. The trial evaluated the safety and efficacy of Ameluz PDT for AK on the extremities, neck, and trunk—vastly larger surface areas where treatment options are often more challenging. According to clinical investigators involved in similar research, dermatologists frequently encounter patients with widespread AK on these parts of the body and have a clear need for better field-directed therapies. An effective, in-office treatment for these regions would represent a significant clinical advancement.

Pending positive data from the trial, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the summer of 2026. An approval would dramatically expand the addressable market for Ameluz and provide dermatologists with a potent tool for managing pre-cancerous lesions across the body.

A Novel Approach to a Stubborn Foe: Acne Vulgaris

Perhaps even more transformative is the company's progress in tackling acne vulgaris. Affecting up to 50 million people annually in the U.S., acne is not just an adolescent affliction; it persists into adulthood for approximately 40% of individuals, often causing significant psychological distress and permanent scarring. The market for acne treatments is valued in the billions, yet significant unmet needs persist.

Current therapies for moderate to severe acne, including oral antibiotics and isotretinoin, are often limited by concerns over systemic side effects and, in the case of antibiotics, the growing threat of antimicrobial resistance. This is the gap Biofrontera hopes to fill.

“Growing concerns about antibiotic resistance, systemic safety, and treatment burden have led dermatologists to look at different approaches to prolonged oral antibiotic and isotretinoin use for the treatment of acne,” commented Prof. Hermann Luebbert, Biofrontera’s CEO, in the company's announcement. He noted that an in-office treatment like Ameluz PDT could also significantly improve patient compliance compared to daily medication regimens.

The database lock for the Phase 2 study of Ameluz in moderate to severe acne is the first major step in this new direction. The company intends to present the study results to the FDA in the third quarter of 2026. This meeting will be crucial for designing a future Phase 3 program, the final step required before seeking marketing approval for Ameluz as a novel, non-systemic acne therapy.

A Strategic Push for Market Expansion

These clinical milestones are not isolated events but rather key components of a broader, aggressive strategy to maximize the value of the Ameluz PDT platform. This push follows another major regulatory filing in December 2025, when Biofrontera submitted an sNDA to the FDA for the use of Ameluz in treating superficial Basal Cell Carcinoma, another form of non-melanoma skin cancer. Together, these initiatives paint a clear picture of a company methodically working to establish its technology as a cornerstone of modern dermatological care.

The recent progress provides a much-needed boost for the company, which has faced financial headwinds, including reported liquidity concerns in late 2025. The positive clinical news and subsequent investor enthusiasm suggest that its strategy may be paying off. A pivotal element of this strategy was a restructured supply agreement in early 2024 that gave Biofrontera Inc. control over its U.S. clinical trials and aimed to pave a path toward profitability. The successful execution of these trials is the first tangible return on that strategic investment.

The path forward is now defined by a series of high-stakes catalysts. The topline data release in February will be the first major test. If positive, the subsequent regulatory submissions for AK this summer and the FDA meeting for acne will be closely watched by patients, physicians, and investors alike. For the millions of Americans affected by these pervasive skin conditions, the coming months will determine if a powerful new light-based therapy is on the horizon.