Opus Genetics Receives FDA Agreement Under Special Protocol Assessment For Phase 3 Trial Of APX3330 In Diabetic Retinopathy; Agreement Reached On Primary Endpoint And Phase 3 Trial Design
Opus Genetics Receives FDA Agreement Under Special Protocol Assessment For Phase 3 Trial Of APX3330 In Diabetic Retinopathy; Agreement Reached On Primary Endpoint And Phase 3 Trial Design
The SPA agreement reflects that the proposed Phase 3 trial design, endpoints, and planned analyses will be adequate to support a New Drug Application (NDA) submission for treatment of NPDR, subject to a successful outcome of the trial and review of all data in the NDA. The agreed primary endpoint is a reduction in 3-step or greater worsening on the binocular diabetic retinopathy severity scale (DRSS) score, compared to placebo. In the previous Phase 2 ZETA-1 trial, oral APX3330 showed the potential to slow or prevent clinically meaningful progression of DR and demonstrated a favorable safety profile.Agreement Reached on Primary Endpoint and Phase 3 Trial Design
達成了關於主要終點和第三階段試驗設計的協議
Oral APX3330 is a Late-Stage Clinical Asset Available for Partnering
口服APX3330是一項可供合作的晚期臨床資產
FARMINGTON HILLS, Mich., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (NASDAQ:IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small-molecule drugs to treat other ophthalmologic disorders, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 clinical trial evaluating oral APX3330 for the treatment of moderate to severe non-proliferative diabetic retinopathy (NPDR).
密歇根州法明頓山，2024年12月19日（全球新聞網）-- Opus Genetics, Inc.（納斯達克：IRD）是一家臨床階段的眼科生物技術公司，致力於開發治療遺傳性視網膜疾病（IRD）的基因療法和用於治療其他眼科疾病的小分子藥物，今天宣佈與美國食品藥品監督管理局（FDA）達成了關於針對口服APX3330治療中度至重度非增殖性糖尿病視網膜病（NPDR）的第三階段臨床試驗的特別協議評估（SPA）。
The SPA agreement reflects that the proposed Phase 3 trial design, endpoints, and planned analyses will be adequate to support a New Drug Application (NDA) submission for treatment of NPDR, subject to a successful outcome of the trial and review of all data in the NDA. The agreed primary endpoint is a reduction in 3-step or greater worsening on the binocular diabetic retinopathy severity scale (DRSS) score, compared to placebo. In the previous Phase 2 ZETA-1 trial, oral APX3330 showed the potential to slow or prevent clinically meaningful progression of DR and demonstrated a favorable safety profile.
SPA協議反映出，提議的第三階段試驗設計、終點和計劃分析將足以支持針對NPDR的新藥申請（NDA）提交，前提是試驗取得成功且審查NDA中的所有數據。達成的主要終點是與安慰劑相比，在雙眼糖尿病視網膜病嚴重程度量表（DRSS）評分上減少3級或更大程度的惡化。在之前的第二階段ZETA-1試驗中，口服APX3330顯示出減緩或防止DR臨床顯著進展的潛力，並展示了良好的安全性特徵。
