Galderma Laboratories has announced that the FDA ( Food and Drug Administration ) has approved Mirvaso ( Brimonidine ) topical gel, 0.33% for the topical treatment of the facial erythema of rosacea in adults 18 years of age or older. Applied once-daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours.

The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso have demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel.
In addition, a long-term study in 276 subjects that used Mirvaso for up to 12-months was also conducted.

Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek.

Mirvaso is safe and well-tolerated. In controlled clinical trials the most common adverse reactions ( incidence greater than or equal to 1% ) included erythema, flushing, skin burning sensation, and contact dermatitis.
In the long-term study, the most common adverse events ( greater than or equal to 4% of subjects ) included flushing ( 10% ), erythema ( 8% ), rosacea ( 5% ), nasopharyngitis ( 5% ), skin burning sensation ( 4% ), increased intraocular pressure ( 4% ), and headache ( 4% ).

Mirvaso gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome.
Alpha-2 adrenergic agents can lower blood pressure.
Mirvaso gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.

Rosacea is a chronic, inflammatory and vascular disorder affecting the face. Redness, visible blood vessels, bumps and blemishes typically appear in the middle of the face ( forehead, nose, cheeks ) after age 30 in men and women. Rosacea affects an estimated 16 million Americans.
Triggers for the condition may include spicy foods, alcohol, emotional stress, sun exposure, and hot baths. Because of the physical manifestation of rosacea on the face, the condition can cause embarrassment, anxiety and frustration and can have a negative impact on the patients’ social life. Stinging, burning, sensitivity of the skin is common, and in some cases, the eyes can become red, dry and itchy. If left untreated, rosacea may worsen. ( Xagena )

Source: Galderma, 2013

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