Galderma now shipping new topical rosacea treatment September 26, 2013
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Galderma headquarters in Fort Worth.
Photo courtesy of Galderma
By Carolyn Poirot
Fort Worth Business Press Health Correspondent
A local company is now selling what is said to be the first-ever topical gel created specifically to combat the facial erythema (redness) of rosacea.
The U.S. Food and Drug Administration approved Mirvaso topical gel, developed by Galderma Laboratories L.P. in late August, and the product reached most pharmacies around the country earlier this month, a company spokesman said Thursday. The product is available by prescription.
“This milestone exemplifies Galderma’s continued, two-decade-long commitment to R&D to address the unmet needs of rosacea patients and clinicians,” said Francois Fournier, president of North American Operations for Galderma Laboratories, headquartered in Fort Worth.
“Mirvaso Gel marks a turning point in rosacea treatment. Mirvaso is going to fill a great vacuum in the armamentarium of products to address the daily stress and anxiety caused by the persistent facial redness of rosacea – providing patients with an effective topical therapy,” Fournier said.
An estimated 16 million Americans are affected by rosacea, a chronic inflammatory and vascular disorder characterized by redness, visible blood vessels, bumps and blemishes on the forehead, nose and cheeks, according to the National Rosacea Society.
Dealing with erythema – the most common symptom of rosacea – every day can be embarrassing and cause anxiety and frustration, a survey from the Rosacea Society found. Some 76 percent of people with the disorder say rosacea’s effect on their facial appearance lowered their self-confidence and self-esteem.
Although the cause of rosacea is unknown, common triggers include sun exposure, emotional stress, hot or cold weather, heavy exercise, alcohol, spicy foods, heated beverages, humidity and certain skin-care products, the Rosacea Society says on its website.
Patients should use the medication as directed by their physicians, but Mirvaso Gel can be used daily to reduce the persistent redness of rosacea, a company spokesman said. Pea-size amounts are applied to each of the five regions of the face: the forehead, chin, nose and each cheek.
More than 45 million people worldwide have symptoms of the disorder, the Rosacea Research & Development Institute says.
Among the most famous rosacea sufferers is former President Bill Clinton, whose diagnosis was reported in the New York Times. Others have included comedian W.C. Fields, Princess Diana, financier J.P. Morgan and the Dutch painter Rembrant, according to the Rosacea Society.
Interest in the new prescription gel that works within 30 minutes of application and lasts up to 12 hours, has been high, and Galderma has been actively meeting with managed care companies working to ensure that patients have access to this first-in-class therapeutic option, a company spokesman said.
Galderma is committed to research and development of new products in dermatology, and several other new medical solutions addressing major dermatological needs will be launched in the next years, Fournier said.
“An innovation such as Mirvaso Gel is a strong example of Galderma’s continuous commitment to investing in skin research and delivering innovative medical solutions to address unmet dermatological needs,” he said. “Galderma has chosen to invest each year approximately 20 percent of its global revenues in research and development.”