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FDA Approves Mirvaso (Brimonidine) for Topical Treatment of Rosacea

Product reduces facial erythema (August 26)

The FDA has approved Mirvaso (brimonidine, Galderma Pharmaceuticals) topical gel, 0.33% for once-daily treatment of the facial redness (erythema) of rosacea in adults 18 years of age or older. The product is expected to be available in pharmacies in September.

The FDA’s approval was based on data collected from more than 550 patients enrolled in two 4-week, phase III clinical studies. In both studies, adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than did those treated with vehicle gel. A study in 276 subjects who used Mirvaso for up to 12 months was also conducted.

Mirvaso (brimonidine) is a topical gel that works by constricting dilated facial blood vessels to reduce the redness of rosacea. The product 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.

Source: Galderma Laboratories; August 26, 2013.

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