Galderma Laboratories, L.P. has announced that the US Food and Drug Administration (FDA) has approved Mirvaso® (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults aged 18 years or older.
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). The condition have a reported prevalence of between 5% and 10%, and usual affects those aged between 30 and 60 years of age.
‘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,’ said Mark Jackson, MD, Clinical Professor of Medicine at the University of Louisville, dermatologist, and a principal investigator for the phase 3 studies of Mirvaso.
‘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.’
Applied once per day, Mirvaso works quickly to reduce the redness of rosacea and lasts for up to 12 hours. Galderma expects Mirvaso to be available in pharmacies this September.
Phase 3 clinical study data
The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies for a duration of 1 month. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel.
In addition, a long-term study of 276 subjects, who 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.
Adverse reactions and condition triggers
In controlled clinical trials the most common adverse reactions of Mirvaso (incidence ≥ 1%) included 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%).
Common triggers for rosacea may include spicy foods, alcohol, emotional stress, sun exposure, and hot baths. Owing to 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.