Allergan公司宣布，F(xiàn)DA已批準面部皮下填充劑Juvederm的最新劑型——Juvederm XC,，這是透明質(zhì)酸（HA）皮下填充劑的最新進展,。Juvederm XC含有局部麻醉劑利多卡因，可以降低使用過程中的不適感,。目前,，Juvederm是首個也是唯一獲得FDA批準在使用后效果可持續(xù)1年的透明質(zhì)酸類面部皮下填充劑,。
Juvederm XC當中的利多卡因含量為0.3%，不含防腐劑,，在使用時麻醉時間可以保持數(shù)秒,，不需再使用其他麻醉劑。該產(chǎn)品效果保持時間與Juvederm相同,，而且經(jīng)過改良之后,，愛美人士不但可以減輕用藥不適之苦，還可以節(jié)省時間,。
這種新型產(chǎn)品獲準的依據(jù)是在一項多中心,、雙盲、隨機臨床實驗當中獲取的數(shù)據(jù),。在實驗中,，72名受試者分別使用Juvederm和Juvederm XC，針對去除鼻唇溝紋,。研究人員在接下來的2周內(nèi)對藥物效果進行跟蹤監(jiān)測,，結(jié)果發(fā)現(xiàn)用Juvederm XC受試組當中93%的人疼痛感更輕，而且其安全性和效果與Juvederm相當,。(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.
