Mirvaso is EU approved for Rosacea - Gladerma

Galderma has announced that the European Commission has granted Marketing Authorisation in Europe on 26 February 2014 for Mirvaso (brimonidine) 3 mg/g gel. It is indicated for the symptomatic treatment of facial erythema (redness) of Rosacea in adult patients. The European Commission decision to grant Marketing Authorisation in Europe for Mirvaso is based on data collected from 553 patients enrolled in two phase III clinical trials of one-month duration. The results from both studies showed that adults with rosacea erythema who used Mirvaso demonstrated significantly greater reduction of the facial redness than the ones who applied vehicle gel only. In addition, a long-term study in 449 subjects who used Mirvaso for up to 12-months demonstrated that Mirvaso was effective and well tolerated.