Galderma’s Mirvaso gel receives FDA approval for erythema of rosacea

The FDA has approved brimonidine topical gel, 0.33% for treatment of facial erythema of adults with rosacea, Galderma Laboratories. L.P. reported today.

Brimonidine (Mirvaso) topical gel, 0.33% is applied once daily and lasts up to 12 hours, according to a press release. It is an alpha-2 adrenergic agonist indicated for topical treatment of persistent facial erythema of rosacea in adults aged 18 years and older, which may work by constricting the dilated facial blood vessels to reduce redness. The product should be in pharmacies by September, Galderma reported.

The FDA approval was based on results of two phase 3 clinical studies of more than 550 adults during a one-month period. In both studies, patients using brimonidine topical gel, 0.33% showed significantly greater improvement in erythema compared with those using vehicle gel, according to the release. Erythema, flushing, skin burning sensation and contact dermatitis were the most common adverse reactions (incidence ≥ 1%), according to the release.

An additional one-year study of 276 individuals using the gel, reported that flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%) and headache (4%) were the most common adverse events (≥ 4% of patients).

The product is to be applied in pea-sized amounts, once daily to five regions of the face, the forehead, chin, nose and each cheek, according to Galderma.

“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,” Mark Jackson, MD, clinical professor of medicine at University of Louisville and researcher in the phase 3 studies. “The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide patients who deal with daily frustrations caused by the redness of rosacea with an effective therapy.”