FDA approves Galderma's Mirvaso topical gel for facial erythema of rosacea

Galderma Laboratories, L.P. announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso^® (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.

“The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy.”

"Facial redness is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need," said Mark Jackson, M.D., Clinical Professor of Medicine at the University of Louisville, dermatologist and a principal investigator for the phase 3 studies of Mirvaso. "The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy."

The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek.

"The FDA approval of Mirvaso provides a first-in-class therapy for facial redness of rosacea that we are proud to add to our existing rosacea portfolio, which includes Oracea^® and MetroGel^® 1% pump," said François Fournier, President of North American Operations, Galderma Laboratories. "This milestone exemplifies Galderma's continued, two-decade-long commitment to R&D to address the unmet needs of rosacea patients and clinicians."

Mirvaso is safe and well-tolerated. In controlled clinical trials the most common adverse reactions (incidence ≥ 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. In the long-term study, the most common adverse events (≥ 4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).