Photocure is developing Visonac®, a novel photodynamic therapeutic treatment for moderate to severe acne. The product is in development phase IIb and it is expected to enter phase III early in 2013.
Visonac is a photodynamic therapy (PDT) that combines the application of Visonac® cream with controlled illumination by a red light source. PDT is based on the accumulation of a photosensitizer in the target cells that upon illumination generate reactive oxygen species, killing the cells. The mechanism of action appears to involve killing of bacteria as well as specific action on sebaceous glands and inflammatory cells. The Visonac® cream is applied to the acne area, and after a short incubation time, the skin is illuminated with red light (see fig. below).
Visonac has shown promising results in phase II studies including patients with moderate to severe acne.
Completion of Phase IIb study enrolment
The current phase IIb study is randomized, double-blind and placebo-controlled and involves patients with moderate to severe acne vulgaris. It will measure safety and efficacy in patients aged 12 to 35, who will receive four treatments over a six week period. Fifteen centres in the US have recruited a total of 150 patients to this study. The centres include both office-based dermatology practices and hospitals. The results are anticipated in 3Q2012 and will support the design of the pivotal phase III studies in the US and Europe. Visonac may be available to patients in Europe in 2015 and the US in 2016.