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FDA Approves Mirvaso, First and Only Treatment Available for Erythema in Rosacea

This approval marks a “turning point” for patients
Payer Perspectives in Dermatology - Rosacea

On August 26, 2013, the US Food and Drug Administration (FDA) approved topical brimonidine gel 0.33% (Mirvaso, Galderma Laboratories) for the treatment of erythema in rosacea in adults aged 18 years and older. This is the first drug approved by the FDA for the treatment of this condition, and it answers an unmet need in addressing the facial erythema that is a hallmark of this skin disorder.

Brimonidine gel 0.33% is a highly selective, alpha-2 adrenergic receptor agonist that acts as a transient vasoconstrictor. This results in reduced facial erythema and attenuation of flushing.

“Facial erythema is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need,” said J. Mark Jackson, MD, Clinical Professor of Medicine at the University of Louisville in Kentucky. Dr Jackson was the principal investigator of the phase 3 clinical studies of this drug.

“The FDA approval marks a turning point in rosacea treatment,” Dr Jackson added. “We are now able to provide patients who deal with the daily frustrations caused by the erythema of rosacea with an effective therapy.”

Clinical Studies Details
Brimonidine gel is applied once daily, and its effect lasts up to 12 hours, according to the results of 2 multicenter phase 3 clinical trials with identical designs involving more than 550 patients. Once-daily application provided significantly greater efficacy and a faster onset of action than the vehicle gel, without evidence of tachyphylaxis, rebound, or aggravation of the other common clinical signs of rosacea.1

The studies included patients with moderate-to-severe erythema who were randomized to receive brimonidine gel 0.33% or to vehicle gel once daily for 4 weeks (with 4 more weeks of follow-up). At the end of treatment, brimonidine gel led to significantly greater improvements compared with the vehicle gel on all efficacy variables.

The primary end point—a 2-grade significant improvement (P <.001) on the clinician’s erythema assessment and on the patient’s self-assessment over 12 hours—was achieved with brimonidine gel 0.33% on day 29 in both studies. Success was achieved by 21% and 23% of patients in the brimonidine gel cohorts in the 2 studies compared with only 10% and 9% in the vehicle gel cohorts. At 12 hours, patients receiving brimonidine gel 0.33% also had more 1-grade improvements compared with the vehicle gel (P <.001). The drug’s effect was noticeable within 30 minutes of the first application.1

Although other therapies are available for the treatment of rosacea, none thus far has specifically targeted the erythema in rosacea, a common characteristic of the disease that is often a source of embarrassment and psychosocial distress for patients.

The new gel should be applied once daily to each of 5 regions on the face—the forehead, chin, nose, and each cheek.

  1. Fowler J Jr, Jackson M, Moore A, et al; for the Brimonidine Phase III Study Group. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12:650-656.
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Last modified: August 30, 2021