Biofrontera Announces Final Patient Enrolled in Phase 3 Trial for Ameluz® Treatment of Actinic Keratoses
WOBURN, Mass., March 18, 2025 – Biofrontera Inc., a pioneering biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), recently made an important announcement. The company reported that they have enrolled the last patient in their Phase 3 clinical trial for Ameluz® (aminolevulinic acid hydrochloride), a potential treatment for mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
Actinic Keratoses: An Overview
Actinic keratoses (AKs) are a common skin condition, typically found on sun-exposed areas of the body. These scaly, rough patches can appear red, pink, or brown and often feel like sandpaper when touched. AKs can be itchy or painless and may develop into squamous cell carcinoma if left untreated. The risk of progression to skin cancer increases with the number and size of AKs, making early detection and treatment crucial.
Expanding Treatment Options for Actinic Keratoses
Currently, treatment options for AKs are limited, primarily focusing on topical and prescription medications or invasive procedures like cryotherapy, electrosurgery, or laser ablation. These treatments can be costly, time-consuming, or cause unwanted side effects. Biofrontera’s Ameluz®, if approved, would offer a new, non-invasive treatment option for patients with AKs on the extremities, neck, and trunk.
The Phase 3 Clinical Trial
The Phase 3 clinical trial, named AK-PDT-III, is a randomized, double-blind, vehicle-controlled study designed to evaluate the safety and efficacy of Ameluz® for the treatment of AKs on the extremities, neck, and trunk. The trial will enroll approximately 500 patients and will be conducted at multiple sites in the United States. The primary endpoint is the complete clearance of AKs at week 12.
Impact on Individuals
For individuals with AKs on sun-exposed areas beyond the face and scalp, the successful approval and commercialization of Ameluz® would provide a much-needed treatment option. This non-invasive therapy could help reduce the risk of progression to squamous cell carcinoma, improve the cosmetic appearance of affected areas, and offer a more convenient and cost-effective alternative to current treatment methods.
Impact on the World
The global market for actinic keratosis treatments is expected to grow significantly in the coming years, driven by an aging population and increasing awareness of the importance of skin cancer prevention and early treatment. Biofrontera’s Ameluz®, if approved, could capture a significant share of this growing market. Moreover, expanding treatment options for AKs beyond the face and scalp would address a critical unmet need in dermatology, improving patient outcomes and quality of life for millions of people worldwide.
Conclusion
Biofrontera’s announcement of the final patient enrolled in the Phase 3 clinical trial for Ameluz® marks an important step forward in the development of a new, non-invasive treatment option for actinic keratoses on the extremities, neck, and trunk. Successful approval and commercialization of this therapy could significantly impact individuals with AKs by reducing the risk of progression to squamous cell carcinoma, improving cosmetic appearance, and offering a more convenient and cost-effective alternative to current treatment methods. Furthermore, this new treatment option could address a critical unmet need in dermatology, contributing to improved patient outcomes and quality of life for millions of people worldwide.
- Biofrontera reports final patient enrolled in Phase 3 trial for Ameluz®
- Ameluz® is a potential treatment for mild to moderate AKs on the extremities, neck, and trunk
- Current treatment options for AKs are limited and often invasive or costly
- Successful approval and commercialization of Ameluz® could provide a much-needed new treatment option
- Global market for actinic keratosis treatments expected to grow significantly
