FDA OKs First Topical Agent for Facial Erythema of Rosacea

Megan Brooks

August 26, 2013

The US Food and Drug Administration (FDA) has approved brimonidine topical gel 0.33% (Mirvaso, Galderma Laboratories) for facial redness resulting from rosacea in adults aged 18 years or older, the company announced today.

Rosacea is a chronic skin condition that affects an estimated 16 million Americans. According to the company, this is the first and only FDA-approved topical treatment specifically developed and indicated for the facial erythema of rosacea.

"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," Mark Jackson, MD, who is clinical professor of medicine at the University of Louisville in Kentucky, a dermatologist, and a principal investigator for the phase 3 studies of Mirvaso, said in a company statement.

"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," he added.

In clinical testing, the alpha 2 adrenergic agonist brimonidine topical gel yielded significantly greater improvement in the facial redness of rosacea than vehicle gel, the company said. Testing included 2 phase 3 clinical trials involving more than 550 patients, each lasting 1 month, and a long-term trial with 276 patients lasting up to 12 months.

Brimonidine topical gel may work by constricting dilated facial blood vessels to reduce the redness of rosacea, the company said. It should be applied in a pea-sized amount once daily to the forehead, chin, nose, and each cheek.

The most common adverse reactions (incidence ≥ 1%) seen in the short-term trials were erythema, flushing, skin burning sensation, and contact dermatitis.

In the long-term study, the most common adverse events (≥4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).

Galderma expects Mirvaso to be available in pharmacies in September.


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