歐康維視生物-B(01477.HK):OT-703獲準於海南博鰲進行真實世界研究
格隆匯5月13日丨歐康維視生物-B(01477.HK)公告,集團產品OT-703(ILUVIEN,氟輕鬆玻璃體植入劑)(是一款可注射的、非生物降解的氟輕鬆玻璃體植入劑,用於治療糖尿病性黃斑水腫(DME))最近已獲準於中國海南省博鰲樂城國際醫療旅遊先行區進行真實世界研究。
OT-703(即190微克氟輕鬆玻璃體內植入劑(0.19毫克))是一款可注射的、非生物降解的氟輕鬆玻璃體植入劑,通過於眼部連續使用最多36個月的微量非專有皮質類固醇醋酸氟輕鬆(FAc)治療DME。其已獲得美國食品藥品監督管理局(FDA)的監管批準,並以商號「ILUVIEN」上市。OT-703是FDA批準的唯一一款緩釋長達3年的治療DME的皮質類固醇眼內植入劑。於2021年4月,公司與AlimeraSciences, Inc.(Alimera)訂立一份獨家許可協議,據此,公司自Alimera獲得ILUVIEN在大中華區、韓國及東南亞11個國家的獨家開發及商業化許可權利。於2023年12月,OT-703獲得香港藥劑業及毒藥管理局的批準,可根據香港法例第138章《藥劑業及毒藥條例》在香港註冊爲醫藥產品。
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