The US Food and Drug Administration (FDA) has approved Galderma’s Mirvaso® (brimonidine) topical gel, 0.33%* for the treatment of rosacea-related redness in adults. Applied once daily, Mirvaso reduces the redness associated with rosacea, and relief lasts up to 12 hours.

Mirvaso may constrict the dilated facial blood vessels to reduce redness. Galderma expects Mirvaso to be available in pharmacies September 2013.

The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of 1-month duration. Study participants who used Mirvaso showed significantly greater improvement in the facial redness than those who used a vehicle gel. Common adverse reactions included erythema, flushing, skin burning sensation, and contact dermatitis.

Joshua Zeichner, MD, an assistant professor of dermatology at Mount Sinai Medical Center in New York City, is excited about the new approval. “Up until this point we have only had drugs to treat the bumps and pus pimples of rosacea. The approval of Mirvaso is very exciting because for the first time, we have a medication to treat facial redness of rosacea which previously could only be addressed with lasers. Facial redness is a significant issue for rosacea patients, so this drug will fill a large unmet need.”