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興齊眼藥(300573.SZ):取得硫酸阿托品滴眼液(0.01%)2年臨牀試驗總結報吿
格隆匯 10-21 16:29

格隆匯10月21日丨興齊眼藥(300573.SZ)公佈,公司研發的硫酸阿托品滴眼液,近日獲得了“硫酸阿托品滴眼液延緩兒童近視進展的有效性和安全性的隨機、雙盲、安慰劑平行對照、多中心2年臨牀試驗”臨牀總結報吿。

該研究是一項隨機、雙盲、安慰劑平行對照、多中心臨牀試驗,486例6-12歲兒童受試者經過了為期2年的用藥觀察,停藥後1年的隨訪觀察,評估硫酸阿托品滴眼液延緩兒童近視進展的有效性和安全性。研究結果顯示,硫酸阿托品滴眼液組對比安慰劑組在主要療效指標上有統計學意義的顯著性差異,硫酸阿托品滴眼液組優於安慰劑組,安全性良好,患者使用依從性好。

目前公司0.01%硫酸阿托品滴眼液已獲得國家藥品監督管理局批准上市,批准適應症為本品用於延緩球鏡度數為-1.00D至-4.00D(散光≤1.50D、屈光參差≤1.50D)的6至12歲兒童的近視進展。截止目前國內尚無其它近視相關適應症的同類產品上市,國外已有同類硫酸阿托品滴眼液產品上市,包括澳大利亞Aspen公司、印度Entod公司等的0.01%硫酸阿托品滴眼液。

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