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Galderma Laboratories Announces Availability of New Mirvaso® (brimonidine) Topical Gel, 0.33%* Pump Dispenser for the Treatment of the Persistent Facial Redness of Rosacea

May 19, 2016

New Pump Delivery System Dispenses a Consistent Dose at Each Use

FORT WORTH, TX, May 19, 2016 – Galderma Laboratories, L.P., a global leader focused on medical treatment options in dermatology and skin health and the maker of Cetaphil®, today announced the availability of a new pump dispenser design for Mirvaso® (brimonidine) Topical Gel, 0.33%* for the treatment of the persistent facial redness associated with rosacea. The Mirvaso Gel Pump is now available by prescription to patients in pharmacies nationwide. The improved delivery system of the Mirvaso Gel Pump dispenses a consistent dose at each use.

Rosacea affects an estimated 16 million Americans, and can often be a challenging condition to manage. Facial redness, also known as erythema, is an extremely common and frustrating symptom of rosacea, affecting up to 93% of sufferers. There currently is no cure for rosacea, but proper treatment can help to control its signs and symptoms.

Originally approved by the U.S. Food and Drug Administration in 2013, Mirvaso Gel is the first and only FDA-approved prescription medication for the treatment of the persistent facial redness of rosacea. Powerful, once-daily Mirvaso Gel works fast to reduce facial redness. When applied once daily, it may start working in as little as 30 minutes and, for some, it can reduce redness for up to 12 hours.

“The availability of the Mirvaso Gel Pump offers a number of benefits to patients with facial erythema,” said Dr. Sandra Johnson, board-certified dermatologist at Johnson Dermatology in Fort Smith, Arkansas and Galderma consultant. “Research proves that the majority of patients prefer a pump dispenser over a tube. As a frequent prescriber of Mirvaso Gel, I am excited for the introduction of this dosing option that is convenient to use for my patients.”

 

About Rosacea

Rosacea is a common inflammatory and vascular disorder, primarily affecting the face. Redness, visible blood vessels, bumps and pimples typically appear in the middle of the face (forehead, nose, cheeks) after age 30 in men and women with rosacea.

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 lives. Stinging, burning and sensitivity of the skin are common, and in some cases, the eyes can become red, dry and itchy. Common triggers for the condition include sun, extreme temperatures, spicy foods, alcohol, emotional stress, certain cosmetics and generally harmless, microscopic Demodex mites found on the skin.

If left untreated, rosacea may worsen. If people suspect that they might have rosacea, they should visit their dermatologist or healthcare provider for diagnosis and to discuss what treatment is right for them.

 

About Galderma

Dating back to 1961, Galderma is now present in 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care professionals around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin, hair and nails.

Strategic brands in the U.S. include Epiduo®, Oracea®, Clobex®, Differin®, Mirvaso®, MetroGel®, Soolantra®, Vectical®, Tri-Luma®, Cetaphil®, Benzac® Acne Solutions, Restylane®, Restylane® Silk, Restylane® Lyft, Dysport® and Sculptra® Aesthetic.

 

Additional information on Mirvaso Gel can be found in the prescribing information at www.mirvaso.com.

 

IMPORTANT SAFETY INFORMATION FOR MIRVASO® GEL

Important Safety Information

Indication: MIRVASO® (brimonidine) Topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events: In clinical trials, the most common adverse reactions (>1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions: 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. Serious adverse reactions following accidental ingestion of MIRVASO Gel by children have been reported. Keep MIRVASO Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit WWW.FDA.GOV/MEDWATCH or call 1-800-FDA-1088.

All trademarks are the property of their respective owners.

 

Contact:

Virginie Naigeon

Director of Corporate Communications

Galderma North America

virginie.naigeon@galderma.com

 

For more information, please visit www.galderma.com and www.galdermausa.com.

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