FDA Approves Mirvaso for Treating Facial Erythema of Rosacea

The FDA recently approved Mirvaso (brimonidine) gel, 0.33% for the topical treatment of the facial erythemaof rosacea in adults 18 years of age or older. According to manufacturer Galderma Laboratories, applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. The company says it expects Mirvaso to be available in pharmacies in September 2013.

The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two Phase III clinical studies of one-month duration. The results of the studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel, according to a company press release. A long-term study in 276 patients 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.

“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, MD, Clinical Professor of Medicine at the University of Louisville, dermatologist and a principal investigator for the Phase II 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.”

According to Galderma, 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 percent of subjects) included flushing (10 percent), erythema (8 percent), rosacea (5 percent), nasopharyngitis (5 percent), skin burning sensation (4 percent), increased intraocular pressure (4 percent), and headache (4 percent).