FDA approves topical rosacea drug

September 9, 2013

The Food and Drug Administration has approved Galderma’s topical gel Mirvaso (brimonidine 0.33 percent) for the treatment of facial erythema from rosacea.

 

The Food and Drug Administration has approved Galderma’s topical gel Mirvaso (brimonidine 0.33 percent) for the treatment of facial erythema from rosacea.

Mirvaso is a once-daily topical treatment to reduce redness from rosacea in patients ages 18 and older. It lasts for up to 12 hours, according to the company. The prescription product should be available in pharmacies this month.

The approval came after the completion of two phase 3 clinical studies of 550 patients, the results of both of which demonstrated an improvement in facial redness of rosacea among patients who used Mirvaso compared to those who used vehicle gel. Another long-term study of 276 patients tested the drug for up to 12 months.

The product should be used in a pea-sized amount once daily to five regions of the face: chin, forehead, nose and each cheek. Mirvaso works by constricting dilated facial blood vessels.

“The FDA approval of Mirvaso marks a turning point in rosacea treatment,” Mark Jackson, M.D., clinical professor of medicine, University of Louisville, said in a news release. “We are now able to provide patients that deal with the daily frustrations caused by the redness of rosacea with an effective therapy.”

In clinical trials, adverse reactions to Mirvaso included erythema, flushing, contact dermatitis and skin burning sensation. Headache, increased intraocular pressure and nasopharyngitis were also reported in the long-term study.

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