FDA批准兰尼单抗治疗DME

美国食品和药物管理局(FDA)已批准兰尼单抗(Ranibizumab，商品名lucentis)注射液(0.3mg)适应证范围用于治疗糖尿病黄斑水肿患者的糖尿病视网膜病变。
FDA的药物评价和研究中心抗菌产品办公室主任EdwardCox，M.D.MPH.说“糖尿病是美国重大的公共卫生问题，每年影响到更多患者。今天的批准使糖尿病黄斑水肿患者的糖尿病视网膜病变患者获得治疗这视觉损害并发症的首个显着疗法。”
FDA称，兰尼单抗的安全性和有效性是基于涉及759例患者的，随访三年的两项临床研究，研究头24个月期间患者被随机赋予接受每月Lucentis注射0.3mg或0.5mg，或无注射。在24个月后，所有患者每个月接收Lucentis或0.3mg或0.5mg.。研究表明，在治疗2年后，雷珠单抗治疗组患者症状得到显着改善。
兰尼单抗最常见的副作用包括结膜出血，眼痛，飞蚊症，眼内压增加。严重的副作用包括眼内炎和视网膜脱离。
FDA的先前之前已批准兰尼单抗治疗继发于视网膜静脉阻塞的DME和黄斑水肿，这两者均会引起液体渗漏到黄斑，从而导致视力模糊
在美国，兰尼单抗也被批准用于新生血管年龄相关性黄斑变性的治疗。兰尼单抗由玻璃体内注射给药，每月注射一次。
FDA称，糖尿病性视网膜病变是最常见的糖尿病眼病，是美国成年人失明的主要原因。
原文链接：http://www.medscape.com/viewarticle/839430
FDAclearsRanibizumabforDiabeticRetinopathyWithDME
TheUSFoodandDrugAdministration(FDA)hasexpandedtheapproveduseofranibizumab(Lucentis，Genentech，Inc)injection(0.3mg)totreatdiabeticretinopathyinpatientswithdiabeticmacularedema(DME).
"Diabetesisaseriouspublichealthcrisis，affectingmorepatientseveryyear，"EdwardCox，MD，MPH，directoroftheOfficeofAntimicrobialProductsintheFDAsCenterforDrugEvaluationandResearch，saidinanewsrelease."Todaysapprovalgivespatientswithdiabeticretinopathyanddiabeticmacularedemathefirstsignificanttherapytotreatthisvision-impairingcomplication."
ThesafetyandefficacyofranibizumabtotreatdiabeticretinopathywithDMEwereestablishedintwoclinicalstudiesinvolving759participantswhoweretreatedandfollowedforthreeyears.Inthetwostudies，treatmentwithranibizumabledtosignificantimprovementinseverityofdiabeticretinopathyattwoyearscomparedwiththatinpatientswhodidnotreceivethedrug，theFDAsays.
Themostcommonsideeffectsincludebleedingoftheconjunctiva，eyepain，floaters，andincreasedintraocularpressure.Serioussideeffectsincludeendophthalmitisandretinaldetachment.
TheFDAgrantedranibizumabfordiabeticretinopathywithDMEbreakthroughtherapydesignationandreviewedthisnewuseforthedrugundertheagencyspriorityreviewprogram，whichprovidesforanexpeditedreviewofdrugsthatdemonstratethepotentialtobeasignificantimprovementinsafetyoreffectivenessinthetreatmentofaseriouscondition.
TheFDApreviouslyhadapprovedranibizumabtotreatDMEandmacularedemasecondarytoretinalveinocclusions，bothofwhichcausefluidtoleakintothemacula，whichcanresultinblurredvision.
RanibizumabisalsoapprovedintheUnitedStatesforthetreatmentofneovascular(wet)age-relatedmaculardegeneration.Ranibizumabisadministeredbyintravitrealinjectiononcemonthly.
DiabeticretinopathyisthemostcommondiabeticeyediseaseandisaleadingcauseofblindnessinadultsintheUS，theFDAsays.

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