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昊海生科(688366.SH):眼內填充用線性交聯透明質酸鈉凝膠臨牀試驗備案並啟動臨牀試驗
格隆匯 08-03 16:49

格隆匯 8 月 3日丨昊海生科(688366.SH)公佈,公司全資子公司上海其勝生物製劑有限公司在研產品眼內填充用線性交聯透明質酸鈉凝膠在臨牀試驗牽頭單位通過倫理會審查,並於近日完成上海市藥品監督管理局的備案。公司已經完成了臨牀試驗的準備工作,認為已經具啟動臨牀試驗的條件,決定啟動臨牀試驗。

產品的應用系國際性創新的技術開發及研究,擬主要用於封堵視網膜裂治療孔源性視網膜脱離。視網膜脱離通常需要通過玻璃體切除治療傳統治療方式需要患者術後保持特定體位(以俯卧位最常見)1-3個月,以使玻璃體腔充物(一般為氣體或硅油填充)對視網膜起到頂壓作用幫助視網膜在生理上及功能上覆位產品預期用於術後可覆蓋並黏附於視網膜裂孔無需額外的填充物頂壓,從而使患者避免術後長期俯卧帶來的痛苦,為患者康復及正常生活帶來極大便利。此外,本產品也有減少術後視網膜下物質逸出帶來的增殖性玻璃體視網膜病變、填充物相關白內障、繼發性青光眼等手術併發症。

產品臨牀試驗按計劃將在7家醫院開展,其中,臨牀試驗牽頭單位啟動患者入組,其餘6家醫院將陸續經過倫理會審查備案並啟動臨牀。以此標誌產品正式進入臨牀試驗階段。

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