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First-in-Class Product Approved for Rosacea-Caused Facial Redness

by U.S. Medicine

November 6, 2013

FT. WORTH, TX — The first treatment for facial erythema in adults caused by rosacea has been approved by the Food and Drug Administration.

Galderma Laboratories announced the approval of Mirvaso (brimonidine) topical gel, 0.33%* for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours.

“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,” said Mark Jackson, MD, a dermatologist at the University of Louisville, and a principal investigator for the Phase 3 studies of Mirvaso. “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.”

Two one-month clinical trials involving more than 550 patients were used to prove the safety and effectiveness of Mirvaso. Results indicated that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. A long-term study in 276 subjects who used Mirvaso for as long as 12-months also was conducted.

Mirvaso appears to constrict 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, according to the manufacturer.


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