Positive Phase III Data On Dusa's Levulan

DUSA Pharmaceuticals has reported positive data from two Phase IIItrials of its photodynamic therapy Levulan (aminolaevulinic acid) in the treatment of precancerous actinic keratoses of the face and scalp.

In the first study, involving 117 patients, 86% of AK lesions in the group receiving Levulan plus a non-laser blue light source (which unlike other PDT modalities can treat an entire face or scalp at once) responded, with 94% clearing after two treatments. In contrast, after two doses of placebo plus blue light, only 32% of lesions had cleared.

The second Phase III study mirrored the first. 81% of AK lesions responded, with 90% clearing after two treatments, compared with a 20% clearance after two treatments in patients receiving placebo plus light. In 90%-94%, the cosmetic appearance of the lesions following treatment was rated as good or excellent. During exposure to light, patients experienced a burning sensation in the AK lesions, but this was well-tolerated, according to the company.