欧康维视生物OT-502获批三期临床试验,纳入博鳌乐城先行区真实世界数据应用试点品种

2021-09-16 JACKZHAO MedSci原创

9月14日,欧康维视生物-B(01477.HK)公布,集团的主要候选药物之一OT-502(DEXYCU®)获中华人民共和国国家医药产品管理局药品审评中心批准于中国开展III期临床试验。

9月14日,欧康维视生物-B(01477.HK)公布,集团的主要候选药物之一OT-502(DEXYCU®)获国家药监局药品审评中心批准于中国开展III期临床试验。

OT-502(9%地塞米松植入剂)是一种新型、可生物降解的单次注射的缓释抗炎药物,可在注射后即刻释放活性成分地塞米松发挥抗炎作用,持续释放21-22天。可生物降解,无需取出。该药物旨在为眼科医生提供一种术毕单次注射缓释激素的选择,能够显著降低患者术后使用眼药水的需求,从而提高患者依从性、改善白内障术后的炎症管理。与此同时,该药物也能帮助患者简化眼科术后护理过程,为眼科术后炎症提供了更好的治疗选择。

OT-502 (DEXYCU®)于2018年2月9日在美国获得食品药品监督管理局(FDA)批准上市,为第一款及唯一一款FDA批准的治疗术后炎症适应症的眼内缓释药物。炎症是白内障手术后常见的症状,倘不及时治疗,可能会导致严重的并发症。迄今为止,临床上常规使用激素和抗生素滴眼液二至四周来治疗术后炎症。然而,白内障手术患者多为老年人,用药依从性较差。OT-502可利用药物递送平台Verisome®将地塞米松递送至前房,直接抑制前房内炎症介质的合成和释放。

OT-502 (DEXYCU®)有效抑制术后前房炎症反应,避免了局部激素滴眼液的频繁使用,有效解决白内障患者术后用药依从性不佳问题,为白内障术后炎症的管理提供更好的治疗选择。

8月17日,欧康维视管线产品OT-502(9%地塞米松植入剂)获国家药监局药品审评中心批准纳入博鳌乐城先行区真实世界数据应用试点品种。截至目前,公司已有两款产品进入真实世界研究试点品种,是国内进入试点品种最多的创新药企。此前,OT-502作为临床急需药物已获得在博鳌乐城超院试点销售资格,并已完成在国内的首例患者注射。

白内障是全球三大致盲眼病之一,据中华医学会眼科学分会统计,我国60至89岁人群白内障发病率约为80%。而90岁以上人群白内障发病率高达90%以上,而目前没有药物能彻底治愈白内障,手术是科学和根本的治疗手段。我国近视人群约7亿,致盲白内障疾病患者约1.9亿。

参考资料:欧康维视生物公告

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    2022-05-18 heli0118
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  5. [GetPortalCommentsPageByObjectIdResponse(id=2030046, encodeId=bd1c203004607, content=<a href='/topic/show?id=59d8196e369' target=_blank style='color:#2F92EE;'>#三期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19673, encryptionId=59d8196e369, topicName=三期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d342500153, createdName=12498bf3m25暂无昵称, createdTime=Mon Sep 20 11:09:08 CST 2021, time=2021-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991341, encodeId=7c9a199134116, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Sun Jan 09 01:09:08 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1690417, encodeId=4d7e169041e5a, content=<a href='/topic/show?id=3238364e0dc' target=_blank style='color:#2F92EE;'>#博鳌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36470, encryptionId=3238364e0dc, topicName=博鳌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Wed May 18 20:09:08 CST 2022, time=2022-05-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1641783, encodeId=71e11641e8315, content=<a href='/topic/show?id=c1bf91e4162' target=_blank style='color:#2F92EE;'>#试点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91741, encryptionId=c1bf91e4162, topicName=试点)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a5522833467, createdName=ms1774076774505970, createdTime=Thu Oct 07 01:09:08 CST 2021, time=2021-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1060806, encodeId=1c24106080646, content=这个就看性价比啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=62595409580, createdName=ms4000000386725740, createdTime=Fri Oct 15 17:32:34 CST 2021, time=2021-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295335, encodeId=8ed91295335f3, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Sep 18 01:09:08 CST 2021, time=2021-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1051831, encodeId=34ba1051831ea, content=学习了先进知识点, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b6e01360690, createdName=lingdie82, createdTime=Thu Sep 16 10:27:13 CST 2021, time=2021-09-16, status=1, ipAttribution=)]
    2021-10-15 ms4000000386725740

    这个就看性价比啦

    0

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  7. [GetPortalCommentsPageByObjectIdResponse(id=2030046, encodeId=bd1c203004607, content=<a href='/topic/show?id=59d8196e369' target=_blank style='color:#2F92EE;'>#三期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19673, encryptionId=59d8196e369, topicName=三期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d342500153, createdName=12498bf3m25暂无昵称, createdTime=Mon Sep 20 11:09:08 CST 2021, time=2021-09-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991341, encodeId=7c9a199134116, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Sun Jan 09 01:09:08 CST 2022, time=2022-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1690417, encodeId=4d7e169041e5a, content=<a href='/topic/show?id=3238364e0dc' target=_blank style='color:#2F92EE;'>#博鳌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36470, encryptionId=3238364e0dc, topicName=博鳌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Wed May 18 20:09:08 CST 2022, time=2022-05-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1641783, encodeId=71e11641e8315, content=<a href='/topic/show?id=c1bf91e4162' target=_blank style='color:#2F92EE;'>#试点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91741, encryptionId=c1bf91e4162, topicName=试点)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a5522833467, createdName=ms1774076774505970, createdTime=Thu Oct 07 01:09:08 CST 2021, time=2021-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1060806, encodeId=1c24106080646, content=这个就看性价比啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=62595409580, createdName=ms4000000386725740, createdTime=Fri Oct 15 17:32:34 CST 2021, time=2021-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295335, encodeId=8ed91295335f3, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Sat Sep 18 01:09:08 CST 2021, time=2021-09-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1051831, encodeId=34ba1051831ea, content=学习了先进知识点, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b6e01360690, createdName=lingdie82, createdTime=Thu Sep 16 10:27:13 CST 2021, time=2021-09-16, status=1, ipAttribution=)]
    2021-09-16 lingdie82

    学习了先进知识点

    0

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