Galderma granted FDA approval
The Switzerland based company has been granted approval for its rosacea fighting topical gel
Switzerland based Galderma Laboratories has been granted approval from the US Food and Drug Administration (FDA) for a gel product which targets rosacea in adults. The company's Mirvaso (brimonidine) topical gel 0.33% is said to serve as a topical treatment for facial redness, or rosacea, in adults 18 years or older. The formula is designed to be applied once daily, and is claimed to reduce the symptoms of rosacea for up to 12 hours. The topical gel, which will be available from September, works by constricting the dilated facial blood vessels to reduce the redness of rosacea, according to Galderma.
"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, Clinical Professor of Medicine at the University of Louisville, dermatologist and a principal investigator for the phase 3 studies of Mirvaso.
The approval of Mirvaso followed data collected from more than 550 patients enrolled in two phase 3 clinical studies over one month. An additional long term study on 276 subjects involving the use of Mirvaso for 12 months was also conducted.
