DUSA Pharmaceuticals, Inc. ® announced today results from its Phase IIB clinical trial to compare the safety and efficacy of photodynamic therapy (PDT) using DUSA’s BLU-U® brand light plus vehicle containing Levulan® (aminolevulinic acid HCl) to that of PDT using the BLU-U plus vehicle without Levulan (the “control group”) in patients with moderate to severe facial acne vulgaris. The study demonstrated that both treatments were safe and well tolerated with no serious adverse events. While both groups showed a statistically significant reduction in inflammatory lesions from baseline, the results did not demonstrate a statistically significant difference between the Levulan PDT and control groups. Based on these results, DUSA will not pursue further clinical development of Levulan PDT in combination with BLU-U for moderate to severe acne.
“In order to justify our continued clinical development, our goal was to demonstrate a 20% difference between the Levulan and the control groups. Although our expectations were not met, the results did demonstrate that all treatment arms were well tolerated and achieved statistical significance for inflammatory lesion reduction from baseline,” said Bob Doman, President and CEO of DUSA. “We will, however, continue to support independent investigator initiated studies in moderate to severe and cystic acne utilizing Levulan with other various treatment regimens and will consider further clinical development if warranted. Also, with the unexpectedly positive results that were achieved on patients with severe acne (Grade 4) using BLU-U plus vehicle without Levulan-approximately a 50% reduction in inflammatory lesions-we intend to file a 510K application with the FDA for an expansion of our BLU-U label to include severe acne,” added Doman. “We believe that if allowed, a claim for blue light treatment of severe acne will increase the value of owning a BLU-U to the dermatology community.”
“The results in these more severe patients in the trial compare favorably to the many topical and systemic therapies, without the potential side effects for the treatment of moderate to severe acne,” said Alan Shalita, M.D., Professor and Chairperson of the Department of Dermatology, Downstate Medical Center, State University of New York (SUNY) and a principal investigator of the study.
DUSA remains committed to, and will focus its resources on continuing to grow the Levulan PDT franchise for the treatment of Grade 1-2 actinic keratoses (AKs) and pursuing other clinical development projects, such as the treatment of AKs and the prevention of squamous cell carcinomas (SCC) in solid organ transplant recipients (SOTR). DUSA expects to begin enrollment in the SOTR study by year end.