First Topical Agent for Facial Erythema of Rosacea Approved

Brimonidine topical gel 0.33% (Mirvaso, Galderma Laboratories) has been approved by the FDA for facial redness resulting from rosacea in adults aged 18 years or older

In clinical testing, the alpha 2 adrenergic agonist brimonidine topical gel yielded significantly greater improvement in the facial redness of rosacea than vehicle gel, according to the company sponsor of the clinical trial. 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 is thought to work by constricting dilated facial blood vessels to reduce the redness of rosacea. It is intended to 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 2013.

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This entry was posted on Tuesday, August 27th, 2013 at 1:49 pm and is filed under Rosacea, Skin Conditions. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

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