General Information

Ameluz (aminolevulinic acid hydrochloride) is a porphyrin precursor.

Ameluz is specifically indicated in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, a narrowband, red light illumination source, for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Ameluz is supplied as a gel for topical administration. Treat single lesions or an entire field affected by multiple lesions with Ameluz, in combination with red light photodynamic therapy (PDT). PDT requires administration of both Ameluz and BF-RhodoLED light. Retreat lesions that have not completely resolved after 3 months after the initial treatment. Refer to BF-RhodoLED user manual for detailed lamp safety and operating instructions.

Clinical Results

FDA Approval

The FDA approval of Ameluz in combination with PDT using a narrow spectrum (red light lamp) source was based on three randomized, multicenter trials (Trials 1, 2, and 3). Trials 2 and 3 were vehicle-controlled and double-blind. Trial 1 was double-blind with respect to vehicle and observer-blind regarding the active comparator arm. All clinical trials included a follow-up assessment after 6 and 12 months. In these trials, 212 subjects with 4 to 8 mild to moderate AK lesions on the face/forehead and/or bald scalp were treated with Ameluz and a narrow band spectrum lamp. In all trials, the lesions that were not completely cleared 12 weeks after the initial treatment were treated a second time with an identical regimen. In the trials, 42% (88/212) of subjects needed a second treatment. The primary endpoint for all trials was complete clearance 12 weeks after the last PDT. Trial 1: 85% versus 13% for placebo; Trial 2: 84% versus 3% and Trial 3: 91% versus 22% for placebo.

Mechanism of Action

Ameluz (aminolevulinic acid hydrochloride) is a porphyrin precursor. Photoactivation following topical application of Ameluz occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells. Ameluz photodynamic therapy of AK lesions utilizes photoactivation of topically applied Ameluz resulting from BF-RhodoLED illumination, which provides a red light of narrow spectrum and a light dose of approximately 37 J/cm2.