Galderma’s Mirvaso (brimonidine) topical gel has received FDA approval for the treatment of persistent facial erythema associated with rosacea in adults 18 years or older.

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Mirvaso, an alpha-2 adrenergic agonist, is a first-in-class once daily topical gel that is believed to work by constricting the dilated facial blood vessels to reduce the redness of rosacea.

Approval of Mirvaso was based on data collected from more than 550 patients enrolled in two Phase 3 clinical studies of one-month duration. The results from both studies demonstrated that adults who used Mirvaso had a significantly greater improvement in the facial redness of rosacea than vehicle gel. The data showed that Mirvaso reduced redness for up to 12 hours. A long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted.

Mirvaso will be available as a 0.33% topical gel in pharmacies September 2013.

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