FDA accepts Sol-Gel’s Investigational New Drug Application for DER45-EV Gel

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel’s Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients.

DER45-EV Gel is an innovative 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.

Rosacea is a common and chronic skin disorder. Affecting mainly fair-skinned, middle-aged and older adults, rosacea is characterized by transient or persistent erythema, papules and pustules. The condition affects more than fourteen million Americans and can cause significant psychological, social and occupational problems if left untreated.

“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,“said Dr. Stanley Shapiro, Sol-Gel’s Head of Skin Care Science & Technology.

“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 innovative core technology, we also hope to achieve a greater therapeutic window in the treatment of rosacea.” added Daniela Mavor, Senior Vice President Business Development.