Merz Aesthetics announced it is now shipping Asclera™ (polidocanol) Injection sclerotherapy treatment to doctors’ offices throughout the U.S. Previously only available in Europe, Asclera™ was recently approved by the U.S. Food and Drug Administration (FDA).
In a study published in the June issue of Phlebology, leading experts conclude that polidocanol is a highly effective sclerotherapy treatment.
Asclera™ was approved by the FDA on March 30 to treat 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 extremities. It has not been studied in larger varicose veins greater than 3 mm in diameter. Once injected, it acts by damaging the cell lining of blood vessels, causing them to close and eventually disappear.
Clinical support for Asclera™ continues to grow.
In the recent Phlebology study, the authors found that polidocanol demonstrated significant efficacy over other treatment options, like sodium tetradecyl sulfate (STS) 1%. In addition, patients reported better satisfaction with polidocanol than with other treatment options. Highlights from the study include:
The treatment success rate for polidocanol was 95% at week 12 and 95% at week 26 vs. 92% and 91% for STS, respectively; both were significantly higher than placebo (P< 0.0001). — The majority of patients treated with polidocanol were satisfied with the treatment. — 87% at week 12 and 84% at week 26 for patients treated with polidocanol — 64% at week 12 and 63% at week 26 for patients treated with STS — 14% at week 12 and 16% at week 26 for patients treated with placebo — Treatment with polidocanol was safe and, apart from local “mild”-to-“moderate” symptoms at the injection site, well tolerated. “The arrival of Asclera™ has been highly anticipated among physicians, with very positive initial reactions and the number of pre-orders exceeding our expectations,” said Dennis Condon, President of BioForm Medical, Inc., a Merz Aesthetics company. “We are proud to finally deliver the next level of cosmetic procedure performance that physicians and patients demand.” Important Safety Information: 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, take care in intravenous needle placement and the smallest effective volume at each injection site should be used.
After the injection session is completed, apply compression with a stocking or bandage, and have the patient walk for 15-20 minutes. Keep the patient under supervision during this period to treat any anaphylactic or allergic reaction, should one occur.
Intra-arterial injection can cause severe necrosis, ischemia or gangrene. If this occurs, consult a vascular surgeon immediately.
Inadvertent perivascular injection of Asclera™ can cause pain. If pain is severe, a local anesthetic (without adrenaline) may be injected.
In clinical studies the following adverse events were observed after using Asclera™: injection site haematoma, injection site irritation, injection site discoloration, injection site pain, injection site pruritus, injection site warmth, revascularization, injection site thrombosis.
Asclera™ is contraindicated for patients with known allergy (anaphylaxis) to polidocanol and patients with acute thromboembolic diseases.
About Merz Aesthetics
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.
Source: Merz Aesthetics