FDA Approves First Sclerosant to Treat Small Varicose Veins in 60 Years
Washington – Merz Aesthetics makes its debut at the prestigious American Society of Aesthetic Plastic Surgeons (ASAPS) annual meeting with the announcement of the U.S. Food and Drug Administration’s (FDA) recent approval of Asclera™ (polidocanol) Injection, a sclerotherapy treatment for uncompplicated spider and reticular veins.
“Spider and reticular veins are a common, often embarrassing condition that can be treated safely and effectively,” said Robert A. Weiss, M.D., director of the Maryland Laser, Skin, and Vein Institute and Associate Professor of Dermatology at Johns Hopkins University School of Medicine in Baltimore, MD. “Asclera™ is a minimally-invasive option for patients who are unhappy with the appearance of their legs.”
The FDA approved Asclera™ (polidocanol) Injection on March 30, 2010 to sclerose uncomplicated spider veins (varicose veins less than or equal to 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity, making it the first sclerosant to be approved in over 60 years. Once injected, Asclera™ acts by damaging the cell lining of blood vessels, causing them to close and eventually be replaced by other types of tissue. Asclera™ is safe and effective when used as directed. Commonly observed local adverse events included injection site hematoma, irritation, and discoloration. Asclera™ has not been studied in varicose veins more than 3 mm in diameter.
“We are very excited about the approval of this treatment, expanding our aesthetics portfolio with products that really matter to patients,” said Dennis Condon, President of BioForm Medical, Inc., a Merz Aesthetics company. “Merz Aesthetics is committed to bringing forward true innovation to solve real problems that impact the lives of aesthetics users, and this takes us in the right direction.”
During the meeting, the company will also unveil the first phase of a unique national consumer survey of women’s experiences and perceptions of minimally-invasive cosmetic procedures. The results shed some light on the underlying motivations behind these women’s cosmetic procedure choices.