Biofrontera, the biopharmaceutical company focusing on sun-induced skin cancer, has announced that preliminary long-term results of the Phase III trial for photodynamic field therapy of actinic keratosis in combination with Biofrontera’s PDT lamp BF-RhodoLED show excellent long term results for patients.
Biofrontera said that this data was a key component in the FDA approval process of Ameluz and BF-RhodoLED and would be included in the safety update for the FDA which is due 120 days after submission.
In October 2014 Biofrontera announced the excellent clearance rates in field treatment and the significant improvement in skin complexion shortly after the last treatment with Ameluz, which is Biofrontera’s first prescription medicine.
According to Biofrontera, all patients treated within the scope of the trial were further monitored by the trial doctors for one year after the last treatment. The aim of this continued patient observation was to analyze the sustainability of Ameluz’s pharmaceutical action in terms of efficacy, safety and cosmetic outcome, the company has said.
Biofrontera further said that, during the trial entire fields of actinic keratoses on the face or scalp were treated with Ameluz in combination with the BF-RhodoLED®. 61.8% of patients were completely cleared from all actinic keratoses after the first treatment cycle with Ameluz. Patients with remaining lesions received a repeated field treatment, resulting in complete clearance of all actinic keratoses in 90.9% of patients.
The German company remarks that new trial data now confirms that one year later 63.3% of the completely cleared patients are still free of symptoms, which reinforces the previous excellent results of the long-term efficacy obtained with Ameluz spot therapy.
The company said that the results demonstrated the impressive sustainability of the skin rejuvenation effect provided by the photodynamic therapy with Ameluz, and that the induced repair processes were active over the course of at least 12 months. Patients thus sustainably benefit from both complete clearance of actinic keratoses as well as the accompanying skin rejuvenation, Biofrontera said.
“It is the first time that data on the aesthetic effect of PDT have been collected during a pivotal Phase III trial. The results emphasize the important role of PDT with Ameluz and BF-RhodoLED and affirm that this therapy clearly stands out from many other treatment options,” it has been concluded in the company’s announcement.