Mirvaso® (brimonidine) topical gel, 0.33%, from Galderma Laboratories, LP, received FDA approval for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older and should be available this month. Mirvaso gel is applied once daily to reduce the redness of rosacea by constricting blood vessels and lasts up to 12 hours.
The Mirvaso gel approval was based on data collected from more than 550 patients enrolled in 2 phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso gel demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects that used Mirvaso gel for up to 12 months was also conducted.
Mirvaso gel is applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek. 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%).
“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,” explains dermatologist Mark Jackson, MD, clinical professor of medicine at the University of Louisville, and a principal investigator for the phase 3 studies of Mirvaso gel. “The FDA approval of Mirvaso gel marks a turning point in rosacea treatment: we are now able to provide patients that deal with the daily frustrations caused by the redness of rosacea with an effective therapy."
