New Drugs and Therapies for 2016: Rosacea

Drs. Neal Bhatia and Ted Rosen

Part 5 of an 8-part series on the large number of new topical and systemic medications that have become available or moved closer to approval in the last 12 months.

Brimonidine 3.3% gel

Rosacea is a chronic relapsing disease of the facial skin, characterized by recurrent episodes of facial flushing, persistent erythema, telangiectasia, papules, and pustules. At present, there is no effective treatment in primary care for the symptoms of flushing and erythema, and management generally consists of lifestyle advice and off-label use of drugs, such as propranolol or clonidine, which may cause significant side effects.

Brimonidine tartrate is a highly selective a₂ adrenergic receptor agonist, with potent vasoconstrictive and vasostabilizing activity. Facial application of brimonidine tartrate reduces erythema through direct cutaneous vasoconstriction. Brimonidine tartrate gel (Mirvaso®) was recently approved for the symptomatic treatment of facial erythema of rosacea in adults. It is an aqueous gel that is applied to the face once every 24 hours, at any time that is suitable for the patient, for as long as facial erythema is present. Approval of Mirvaso was based on results from two randomized, vehicle-controlled phase III trials that included 553 patients. The primary efficacy end point was the ‘success rate’, defined as a 2-grade improvement on both the Clinician’s Erythema Assessment (CEA) and Patient’s Self‑Assessment (PSA) over 12 hours on days 1, 15 and 29. Results from these studies indicated that once-daily brimonidine 3.3% gel had a good safety profile and provides significantly greater efficacy vs vehicle gel for the treatment of moderate to severe erythema of rosacea.