Ameluz (aminolevulinic acid) / Biofrontera - LARVOL DELTA

Biofrontera…announced that the…FDA has approved the Company's supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults (GlobeNewswire) - "With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer....The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle."

FDA approval • Basal Cell Carcinoma

Successful use of daylight photodynamic therapy with BF-200 ALA combined with oral itraconazole for the treatment of inflammatory tinea capitis caused by Microsporum canis. (PubMed, Rev Iberoam Micol) - No abstract available

Journal • Dermatology

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (clinicaltrials.gov) - P3 | N=172 | Completed | Sponsor: Biofrontera Inc. | Active, not recruiting ➔ Completed

Trial completion • Actinic Keratosis • Dermatology

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Biofrontera Inc. | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

The Efficacy of an Optimized, Low-Intensity Photodynamic Therapy Protocol with 10% 5-ALA Nanoemulsion in Refractory Vulvar Lichen Sclerosus: Impact on Quality of Life and Sexual Function. (PubMed, J Clin Med) - " Forty patients with refractory VLS underwent PDT using a 10% 5-aminolevulinic acid nanoemulsion (Ameluz®) applied to lesions under an occlusive aluminum foil dressing...Our findings also suggest that the cumulative number of PDT sessions is a key factor for clinical response. Further studies should address long-term outcomes."

HEOR • Journal • Dermatology • Oncology

Efficacy and safety of ALA/MLA photodynamic therapy for superficial and nodular basal cell carcinoma: a systematic review and meta-analysis. (PubMed, Front Oncol) - "Novel PDT formulations including BF-200 ALA-PDT and AFL-MAL-PDT demonstrate promising CR rates for BCC, providing new treatment alternatives for clinical practice. Standardization of treatment parameters (e.g., light dose, treatment sessions) and differentiation of study design types can effectively reduce heterogeneity in PDT efficacy evaluation, and ALA/MAL-PDT should be prioritized for patients seeking minimally invasive treatment, those with multiple lesions, or those with contraindications to surgical excision."

Journal • Retrospective data • Review • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Skin Nodular Basal Cell Carcinoma • Solid Tumor

Biofrontera Inc…announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED red-light lamp series for the treatment of sBCC. (GlobeNewswire) - "The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026."

FDA filing • PDUFA • Basal Cell Carcinoma

Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically (clinicaltrials.gov) - P=N/A | N=125 | Recruiting | Sponsor: Dartmouth-Hitchcock Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Oncology • Skin Cancer • Solid Tumor

Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Sherrif Ibrahim | Recruiting ➔ Completed

Trial completion • Actinic Keratosis • Dermatology

P129 A prospective comparative audit of outcomes in patients with basal cell carcinoma receiving 10 600-nm carbon dioxide laser-assisted photodynamic therapy with either methyl aminolaevulinate or 5-aminolaevulinic acid as a photosensitizer. (PubMed, Br J Dermatol) - "The photosensitizer was applied topically according to availability, and incubated for 3 h. The photosensitizer was either MAL 160 mg g-1 cream (Metvix; Galderma, Lausanne, Switzerland) or 5-ALA 78 mg g-1 gel (Ameluz; Biofrontera, Leverkusen, Germany). This study concludes that ALA-PDT has a lower overall and 2-year recurrence rate than MAL-PDT. The rate of complications was lower for MAL-PDT than for ALA-PDT, and the cosmetic outcomes for MAL-PDT were slightly better than for ALA-PDT when assessed using mean Vancouver Scar Scores."

Clinical • Journal • Anesthesia • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz-PDT (GlobeNewswire) - "The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera’s U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz label to include treatment of sBCC treatment with PDT using its BF-RhodoLED or RhodoLED XL red light lamps."

FDA filing • Basal Cell Carcinoma

Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically (clinicaltrials.gov) - P=N/A | N=125 | Not yet recruiting | Sponsor: Dartmouth-Hitchcock Medical Center

New trial • Genetic Disorders • Oncology • Skin Cancer • Solid Tumor

Efficacy and Tolerability of Two Low-Irradiance Red Light Photodynamic Therapy Regimens in Actinic Keratosis of the Head and Scalp: A Clinical Trial with BF-200 ALA (EADV 2025) - "Both half-dose PDT protocols demonstrated high efficacy and good tolerability for AKs on the head and scalp. While Group A achieved superior lesion clearance, Group B offered a significantly better pain profile with still excellent clinical outcomes. Both regimens may represent valuable options for treating mild-to-moderate cancerization fields, allowing for treatment individualization based on patient needs and tolerability"

Clinical • Actinic Keratosis • Dermatology

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. (PubMed, J Am Acad Dermatol) - "10% ALA gel showed significantly higher clearance rates than vehicle with unproblematic safety and positive esthetic outcome."

Clinical • Journal • P3 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp. (PubMed, J Eur Acad Dermatol Venereol) - P3 | "We showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients."

Clinical • Journal • P3 data • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Sherrif Ibrahim

New P1 trial • Actinic Keratosis • Dermatology

Biofrontera Inc. Announces Major Restructuring of Relationship With Biofrontera AG Backed By $11 Million Investment (GlobeNewswire) - "Biofrontera Inc...announced today that it has acquired all U.S. Rights to Ameluz and RhodoLED from its former parent company Biofrontera AG. An $11 million investment led by Rosalind Advisors, Inc. and AIGH Capital Management LLC funded the acquisition and transfer costs...Biofrontera Inc. will now pay a monthly Ameluz royalty of 12% in years where Ameluz revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The new royalty replaces the former transfer pricing model — which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. As part of the agreement, Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the entities."

Commercial • Actinic Keratosis

Topical 5-Aminolevulinic Acid Photodynamic Therapy for Actinic Keratosis Increases Skin Elasticity and Hydration. (PubMed, Photodiagnosis Photodyn Ther) - "Topical PDT improves skin hydration and elasticity. It is a promising strategy for photorejuvenation for people aged >70 years. Future studies using large cohorts and long follow-up duration should be conducted to validate our results."

Journal • Actinic Keratosis • Aesthetic Medicine • Dermatology

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Case Comprehensive Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Jul 2024

Trial completion • Trial completion date • Actinic Keratosis • Dermatology • Pain

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults (clinicaltrials.gov) - P2 | N=126 | Active, not recruiting | Sponsor: Biofrontera Bioscience GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

Red-Light Photodynamic Therapy with 10% Aminolevulinic Acid (ALA) Following Microneedling in the Treatment of Facial Actinic Keratosis: Cosmetic and Clinical Outcomes. (PubMed, J Clin Aesthet Dermatol) - "We evaluated the cosmetic outcome and clearance of actinic keratoses (AKs) using photodynamic therapy (PDT) with microneedling-assisted delivery of 10% aminolevulinic acid (ALA) gel (Ameluz®, Biofrontera, Woburn, MA) with 30-minute incubation followed by 10-minute illumination with a red light (BF-RhodoLED®, 635nm, 37 J/cm2)...The study included a small number of subjects (N=5). Our results indicate that red light PDT using microneedling-assisted delivery of 10% ALA gel and a short 30-minute incubation is a safe and tolerable procedure producing good cosmetic outcomes in several skin quality parameters, such as texture and skin tone evenness, as well as an AK lesion clearance rate of 89.2 percent at Week 8, relatively low pain scores, and a reduced PDT treatment time."

Clinical data • Journal • Actinic Keratosis • Dermatology • Pain

A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of 10% Aminolevulinic Acid Gel in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp with Red Light Photodynamic Therapy. (PubMed, J Clin Aesthet Dermatol) - "Although the allowed use of pain-reducing measures might have influenced evaluation of pain, it reflects how the procedure is managed in current practice. PDT with 10% ALA gel and red light illumination on an expanded treatment field was generally well tolerated."

Clinical • Journal • Actinic Keratosis • Dermatology • Pain

Biofrontera Inc. Reports Record Fiscal Year 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "Reported record total revenues of $37.3 million for 2024, reflecting a 9.5% increase from $34.1 million in 2023 with Q4 2024 growing 18.5% over Q4 2023. The growth was primarily driven by increases in Ameluz sales volume and unit price...Total revenues for the fourth quarter of 2024 were $12.6 million, an increase of $2.0 million, or 18.5%, compared with $10.6 million for the fourth quarter of 2023. This growth reflects the continued adoption of Ameluz..."

Commercial • Basal Cell Carcinoma

Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk (GlobeNewswire) - "Biofrontera Inc...today announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk...Expanding field treatment options for AKs beyond the face and scalp would address a critical unmet need in dermatology....With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by Q2 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026."

Enrollment closed • FDA filing • Trial status • Actinic Keratosis

Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp (clinicaltrials.gov) - P3 | N=172 | Active, not recruiting | Sponsor: Biofrontera Bioscience GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Actinic Keratosis • Dermatology