FDA Approval of Asclera to Treat Varicose Veins

Author: Merz Aesthetics
Published: 2010/04/24 - Updated: 2010/05/29
Category Topic: FDA News and Approvals - Academic Publications

Page Content: Synopsis - Introduction - Main

Synopsis: Approval of Asclera (polidocanol) Injection a sclerotherapy treatment for uncomplicated spider and reticular veins.

Introduction

Main Content

Following news of the acquisition of BioForm Medical, Inc. earlier this year, Merz Aesthetics, the new business unit of Merz Pharma Group, 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 uncomplicated 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. See Important Safety Information.

"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."

With Merz's recent acquisition of BioForm Medical, Inc. the company is now distinguished by its rich and diverse product portfolio that, in addition to Asclera , includes RADIESSE® dermal filler as well as several innovative aesthetics products under development.

"The union of BioForm Medical and Merz Aesthetics comes at an interesting time, with the field of aesthetics growing through increased public acceptance in procedures overall, as well as an increase in the number of products and treatments that address all aspects of body image," said Julius W. Few, M.D., FACS, board-certified plastic surgeon, Founder of The Few Institute for Aesthetic Plastic Surgery in Chicago, Ill and chair of ASAPS Cosmetic Medicine Committee. "I am constantly looking for innovative cosmetic procedures that will help my patients discover new ways to reach their aesthetic goals."

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.

Merz Aesthetics, the new business unit of Merz Pharma Group, is a leader in the global aesthetic medicine market. With a 100-year history of compassion and innovation in healthcare, Merz Aesthetics is committed to delivering a new generation of aesthetic care.

BioForm Medical, Inc. is a wholly-owned subsidiary of Merz, Inc. Headquartered in San Mateo, California, BioForm Medical, Inc. is focused on developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is RADIESSE® dermal filler, a long-lasting filler for use in facial aesthetics.

Important Safety Information:

For intravenous use only. Asclera (polidocanol) Injection is indicated 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. Asclera has not been studied in varicose veins more than 3mm in diameter. Severe allergic reactions have been reported following polidocanol use, including anaphylactic reactions, some of them fatal. Severe reactions are more frequent with use of larger volumes (>3 mL). The dose of polidocanol should therefore be minimized. Be prepared to treat anaphylaxis appropriately. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, care should be taken in intravenous needle placement and use the smallest effective volume at each injection site should be used. Commonly observed local adverse events included injection site hematoma, irritation, and discoloration. Asclera is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.