FDA Accepts Sol-Gel’s IND Application For Rosacea

FDA has acknowledged receipt of Sol-Gel Technologies’ (Sol-Gel) Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. The IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients.

DER45-EV Gel is a topical product based on Sol-Gel’s patented drug delivery system that is designed to enhance the efficacy, safety and stability of topical drugs. Sol-Gel’s technology does so by encapsulating the active ingredients in an inert, clear-silica microcapsule shell and by releasing the ingredients in a time-controlled manner.

Stanley Shapiro, head of skin care science & technology at Sol-Gel, said: “As Sol-Gel’s microcapsulation forms a protective barrier between the drug and the skin, we expect it to reduce irritation when applied to the relatively sensitive skin of rosacea patients.”

Daniela Mavor, senior vice president of business development at Sol-Gel, said: “Comparative clinical studies performed in the treatment of acne, presented at the 10th International Congress of Dermatology in Prague, May 20-23, 2009, confirmed that the Sol-Gel drug delivery technology provides improved efficacy, when compared to a marketed topical formulation. Using our core technology, we also hope to achieve a greater therapeutic window in the treatment of rosacea.”