FDA Approves Asclera (Polidocanol) for Treatment of Spider Veins and Varicose Veins

July 20, 2010 - PRLog -- FDA Approves Asclera (Polidocanol)
In a news release on March 30th, the United States Food and Drug Administration (FDA announced the approval of Asclera (Polidocanol) for the treatment of uncomplicated spider and reticular veins. Asclera will be distributed by Bioform Medical, Inc (San Mateo, California). BioForm Medical, Inc. is a medical aesthetics company that is known for
its product RADIESSE ®, a dermal filler used in facial aesthetics. It will be manufactured by Chemische Fabrik Kreussler & Co. (Germany), who presently
manufactures the sclerosant in Europe under the trade name Aethoxysklerol®
The commercial introduction of Polidocanol into the U.S. market has been long anticipated. Kreussler began clinical trials for FDA approval in the United
States in 1999. In 2007, Kreussler entered into an exclusive
agreement with Bioform for its distribution in the United States upon FDA approval. In July 2008, Kreussler submitted data to the FDA demonstrating
that Polidocanol met the primary endpoint of its Phase III clinical trial. The EASI study successfully met its primary efficacy endpoint with demonstrated
statistically significant superiority (p 3 mm in diameter. Sclerosants in foam form are still not approved by the FDA.
Production of microfoam from a sclerosing solution is a chemical alteration and currently an off-label use. Bioform anticipates taking orders for Asclera in
mid-April and shipping is anticipated in June. Pricing
information is not yet available.


FDA Approves Asclera to Treat Small Varicose Veins

The U.S. Food and Drug Administration today approved Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins.

Although they usually occur in the legs, varicose veins also can form in other parts of the body. Factors such as genetics, age, female gender, pregnancy, obesity, and prolonged periods of standing may increase the risk for varicose veins.

“Varicose veins are a common condition,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance.”

Asclera is approved to close spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter). Asclera acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue.

Common adverse reactions to Asclera include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site.

Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany.

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Laser Lipo and Veins Medical Center is dedicated to treating the painful symptoms and underlying causes of vein disease through the latest innovations in laser technology. We treat all types of vein disease from varicose and spider veins to thread veins.