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
达成了关于主要终点和第三阶段试验设计的协议
Oral APX3330 is a Late-Stage Clinical Asset Available for Partnering
口服APX3330是一项可供合作的晚期临床资产
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).
密歇根州法明顿山，2024年12月19日（全球新闻网）-- Opus Genetics, Inc.（纳斯达克：IRD）是一家临床阶段的眼科生物技术公司，致力于开发治疗遗传性视网膜疾病（IRD）的基因疗法和用于治疗其他眼科疾病的小分子药物，今天宣布与美国食品药品监督管理局（FDA）达成了关于针对口服APX3330治疗中度至重度非增殖性糖尿病视网膜病（NPDR）的第三阶段临床试验的特别协议评估（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协议反映出，提议的第三阶段试验设计、终点和计划分析将足以支持针对NPDR的新药申请（NDA）提交，前提是试验取得成功且审查NDA中的所有数据。达成的主要终点是与安慰剂相比，在双眼糖尿病视网膜病严重程度量表（DRSS）评分上减少3级或更大程度的恶化。在之前的第二阶段ZETA-1试验中，口服APX3330显示出减缓或防止DR临床显著进展的潜力，并展示了良好的安全性特征。
