SKINMEDICA'S WATER-BASED ECZEMA TREATMENT APPROVED

SkinMedica announced that the FDA has approved the company's new drug application (NDA) for Desonate (desonide gel) 0.05 percent for treatment of mild to moderate atopic dermatitis. Desonate is a low potency topical steroid formulated in a proprietary water- based Hydrogel vehicle developed and patented by Dow Pharmaceutical Sciences. The patented formula is free from alcohol, fragrance or surfactants, which can be irritating or drying to the skin of atopic dermatitis patients. Desonate was developed in a collaborative effort between SkinMedica and Dow Pharmaceutical and will be available to physicians in first quarter of 2007.

Desonate is the first product to contain 0.05 percent desonide in an aqueous-based Hydrogel formulation free from alcohol, fragrances or surfactants. The safety and efficacy of Desonate was demonstrated in two Phase III clinical trials with a total of 582 mild-to-moderate atopic dermatitis subjects ages 3 months to 18 years. The results demonstrated a statistically significant treatment effect for Desonate compared with placebo in both primary and secondary endpoints.

The patented formula is designed to provide a comfortable, nonirritating, smooth feel that will not leave a greasy residue. In two pivotal clinical trials, application site burning was reported by only 1 percent and pruritus (itching) by less than 1 percent of all treated patients. The product is approved for use in children over 3 months of age and for adults who suffer from the chronic itching and inflammatory symptoms of atopic dermatitis, commonly known as eczema. The safety and efficacy of Desonate was established for up to four weeks of use, and the product is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.