The US Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, produced by Galderma Laboratories, for the topical treatment of the facial erythema (redness) of Rosacea in adults with 18 years or above.
With a 12 hour lasting capacity, Mirvaso can be applied once daily for immediate effect. Galderma believes that the medicine will be available in pharmacies in September 2013.
The company said that Mirvaso, which affects by constricting the dilated facial blood vessels to reduce the redness of rosacea, should be applied as a droplet amount once daily on the forehead, chin, nose and each cheek.
The FDA approval comes following inspection of data from over 550 patients enrolled in two phase III clinical trials lasting one-month, which showed that adults treated with Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel.
Mirvaso dermatologist, phase III studies principal investigator and the University of Louisville clinical professor of medicine Mark Jackson said 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.
"The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy," Jackson added.
