Allergan公司宣布,FDA已批准面部皮下填充剂Juvederm的最新剂型——Juvederm XC,这是透明质酸(HA)皮下填充剂的最新进展。Juvederm XC含有局部麻醉剂利多卡因,可以降低使用过程中的不适感。目前,Juvederm是首个也是唯一获得FDA批准在使用后效果可持续1年的透明质酸类面部皮下填充剂。
Juvederm XC当中的利多卡因含量为0.3%,不含防腐剂,在使用时麻醉时间可以保持数秒,不需再使用其他麻醉剂。该产品效果保持时间与Juvederm相同,而且经过改良之后,爱美人士不但可以减轻用药不适之苦,还可以节省时间。
这种新型产品获准的依据是在一项多中心、双盲、随机临床实验当中获取的数据。在实验中,72名受试者分别使用Juvederm和Juvederm XC,针对去除鼻唇沟纹。研究人员在接下来的2周内对药物效果进行跟踪监测,结果发现用Juvederm XC受试组当中93%的人疼痛感更轻,而且其安全性和效果与Juvederm相当。(生物谷Bioon.com)
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Allergan gets FDA approval for new Juvéderm XC
The Irvine-based firm's improved formula provides the same wrinkle treatment but with less pain.
Irvine-based Botox maker Allergan has received approval from the U.S. Food and Drug Administration for Juvéderm XC, a dermal filler that can also reduce pain during the treatment of facial wrinkles.
The therapy is a new form of Allergan's already FDA-approved Juvéderm injectable gel product. The XC version contains lidocaine, a local anesthetic that provides increased comfort to patients during the treatment of areas such as the nasolabial folds that occur around the nose and mouth. Juvéderm XC provides the same results as the formerly approved product, but the injection experience will be less painful.
The product is touted as the first hyaluronic acid dermal filler approved by the FDA that lasts up to one year after the initial treatment.
“Allergan is committed to providing the latest scientific advancements in facial aesthetic products to meet patients’ demands and further optimize their experiences,” says Robert Grant, the company's corporate vice president and president of Allergan Medical.