The U.S. food and Drug Administration (FDA) has just approved a new topical gel for the treatment of rosacea (erythema). The gel, Mirvaso (brimonidine) is made by Galderma Laboratories, of Fort Worth, Texas. Mirvaso was approved based on two month-long clinical trials that involved more than 550 patients.
According to Dr. Mark Jackson, lead investigator and dermatologist and clinical professor of medicine at the University of Louisville in Kentucky, “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 that deal with the daily frustrations caused by the redness of rosacea with an effective therapy.”
Dr. Joshua Zeichner, director of cosmetic and clinical research in the department of dermatology at Mount Sinai Medical Center, in New York City, remarks, “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.”
It is believed that some 16 million patients in the U.S. are affected by rosacea which is most common in individuals over the age of 30. Rosacea involves chronic inflammation and vascular issues that affect the face which in turn generates redness and visible blood vessels. This has the affect of impairing the appearance of the forehead, nose and cheeks.
According to Galderma, studies that led to Mirvaso’s (brimonidine) approval demonstrated that Mirvaso performed better than an inactive placebo gel. Galderma also noted that there was another trial conducted for a one year period involving 276 patients. They report that Mirvaso side effects were rare. Less than 4 percent of the patients demonstrated reactions such as flushing, redness, burning or headache. Mirvaso is meant for adults 18 years and older and should be used with caution by individuals who have depression, heart disease or autoimmune disorders.
Galderma explains that Mirvaso is believed to work by constricting dilated facial blood vessels, thereby, reducing the appearance of redness. Mirvaso gel is applied daily to the chin, nose, cheeks and forehead. Mirvaso gel will be in pharmacies in September.
According to Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City, “This will not replace the need for other rosacea treatments for control of breakouts.” She cautions that Mirvaso should not be seen as a cure.