FDA Approves Use of Three Tubes of Ameluz Gel in One Treatment

The U.S. Food and Drug Administration (FDA) has approved Biofrontera Inc.'s Supplemental New Drug Application (sNDA), permitting an increased dosage of Ameluz® from one to three tubes per treatment for photodynamic therapy (PDT) targeting actinic keratosis (AK) on the face and scalp. This significant approval provides healthcare professionals greater flexibility in treating larger or multiple areas, enhancing convenience for both doctors and patients. Biofrontera Inc. is a biopharmaceutical company focused on the commercialization of dermatologic products.

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed his delight with the FDA's approval, highlighting that the company is now collaborating with Medicare and commercial payers to secure reimbursement for the updated label. Customers will be informed accordingly.

The sNDA approval was bolstered by two Phase I safety studies involving 116 patients, in which three tubes of Ameluz® were applied. These studies demonstrated that the concentrations of the active ingredient and its metabolite in the blood were significantly lower than levels known to cause side effects. Moreover, the adverse events at the systemic and application site were similar to those observed when using a single tube of Ameluz®.

Ameluz® is unique as the only PDT photosensitizer approved by the FDA for both lesion-directed and field-directed treatment of AKs. This approval allows dermatologists to offer a more comprehensive treatment option while maintaining Ameluz®'s proven efficacy and safety profile. Dr. Luebbert emphasized that this milestone showcases Biofrontera's ongoing commitment to PDT and the development of this vital treatment method.

Dr. Jonathan Weiss, an investigator and co-managing partner at Georgia Dermatology Partners in Atlanta, noted that up to 60% of squamous cell carcinomas originate from untreated AK lesions. He highlighted the importance of treating the entire affected area and shared his positive experience using Ameluz® over the past seven years for managing AK due to its demonstrated efficacy and safety. Dr. Weiss looks forward to utilizing up to three tubes for patients needing such extensive treatment following the sNDA approval.

Actinic keratosis is a prevalent pre-cancerous skin lesion caused by chronic sun exposure, potentially progressing to life-threatening squamous cell carcinoma if untreated. AKs typically manifest on sun-exposed areas such as the face, bald scalp, arms, or the back of the hands. In 2020, approximately 58 million people in the U.S. were affected by AK, with 13 million treatments conducted that year.

Biofrontera Inc., based in the U.S., specializes in dermatological treatments with a focus on PDT. The company commercializes Ameluz® in combination with the RhodoLED® lamp series for PDT of AK, aiming to prevent progression to invasive skin cancers. Biofrontera conducts clinical trials to broaden the use of their products, including treating non-melanoma skin cancers and moderate to severe acne.

In summary, the FDA's approval for the use of up to three tubes of Ameluz® in treating actinic keratosis represents a significant advancement, offering enhanced treatment flexibility and improved patient care. This milestone underscores Biofrontera Inc.'s dedication to providing effective dermatological treatments and their ongoing commitment to advancing PDT.