Scholarlink

Introduction <p>This study aims to evaluate the efficacy, safety, and immunogenicity of ZRC-3285 (aflibercept biosimilar) with Eylea<sup>®</sup> (aflibercept) in patients with neovascular (wet) age-related macular degeneration (nAMD).</p> Methods <p>This phase&#xa0;III, multicenter, double-blind study was conducted across 27 sites in India and randomized (2:1) patients with nAMD into either the test aflibercept (ZRC-3285, Zydus Lifesciences Ltd.) or Eylea<sup>®</sup> (Regeneron Pharmaceuticals, Inc.) groups. All 184 enrolled patients (122 and 62 in the ZRC-3285 and Eylea<sup>®</sup> groups, respectively) were included in the modified intend-to-treat (mITT) population. ZRC-3285 or Eylea<sup>®</sup> was administered by intravitreal injection at a dose of 2&#xa0;mg (0.05&#xa0;mL) on days&#xa0;1, 29, and 57. The primary objective was to assess non-inferiority of ZRC-3285 versus Eylea<sup>®</sup> in treating nAMD and was evaluated by determining the proportion of patients who lose fewer than 15 letters from baseline visual acuity over 12&#xa0;weeks using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Secondary objectives included comparison of additional efficacy outcomes, immunogenicity, and safety.</p> Results <p>Over 12&#xa0;weeks, all patients in the ZRC-3285 (122, 100%) and Eylea<sup>®</sup> (62, 100%) groups showed loss of fewer than 15 letters, demonstrating non-inferiority [95% confidence interval (CI) not evaluable (NE); <i>p</i> = NE)] of ZRC-3285 to Eylea<sup>®</sup>. The proportion of patients who gained more than 15 letters in best corrected visual acuity (BCVA) over 12&#xa0;weeks and the mean changes in BCVA, choroidal neovascularization (CNV), and central retinal thickness (CRT) were similar in both arms.</p> Conclusion <p>Efficacy, immunogenicity, and safety profiles of ZRC-3285 were found to be similar to those of Eylea<sup>®</sup>.</p> Trial Registration <p>Clinical trial Registry of India (CTRI): CTRI/2023/09/057655 [Registered on 14/09/2023].</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A Phase III Randomized Trial Comparing Efficacy, Safety, and Immunogenicity of ZRC-3285 vs. Eylea® in Patients with Wet Age-Related Macular Degeneration

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月23日

查看全文
  • Mudit Bansal,
  • Punit Singh,
  • Ruchi K. Mehta,
  • Rohit Sanjay Laul,
  • Parth Rana,
  • Urmil Shah,
  • Rajpal Vohra,
  • Shachi Desai,
  • Sharad Bhomaj,
  • Sourabh Patwardhan,
  • Jaishri Murli Manoher,
  • Anjali Sapar,
  • Sandeep Parwal,
  • Ajay Kartik Amabde,
  • Rahul Shroff,
  • Sribhargava Natesh,
  • Rupak Kanti Biswas,
  • Lional Raj D,
  • Bibhuti P. Sinha,
  • Minija C K,
  • Ekta Patel,
  • Ashish Kamble,
  • Pramod Bhende,
  • Sandeep Patil,
  • Anup Shah,
  • Ritesh Narula,
  • Bandana Kumari,
  • Lokesh Bathula,
  • Sandip Kirtane,
  • Bhargav Darji,
  • Maulik Doshi,
  • Deven Parmar

摘要

Introduction

This study aims to evaluate the efficacy, safety, and immunogenicity of ZRC-3285 (aflibercept biosimilar) with Eylea® (aflibercept) in patients with neovascular (wet) age-related macular degeneration (nAMD).

Methods

This phase III, multicenter, double-blind study was conducted across 27 sites in India and randomized (2:1) patients with nAMD into either the test aflibercept (ZRC-3285, Zydus Lifesciences Ltd.) or Eylea® (Regeneron Pharmaceuticals, Inc.) groups. All 184 enrolled patients (122 and 62 in the ZRC-3285 and Eylea® groups, respectively) were included in the modified intend-to-treat (mITT) population. ZRC-3285 or Eylea® was administered by intravitreal injection at a dose of 2 mg (0.05 mL) on days 1, 29, and 57. The primary objective was to assess non-inferiority of ZRC-3285 versus Eylea® in treating nAMD and was evaluated by determining the proportion of patients who lose fewer than 15 letters from baseline visual acuity over 12 weeks using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Secondary objectives included comparison of additional efficacy outcomes, immunogenicity, and safety.

Results

Over 12 weeks, all patients in the ZRC-3285 (122, 100%) and Eylea® (62, 100%) groups showed loss of fewer than 15 letters, demonstrating non-inferiority [95% confidence interval (CI) not evaluable (NE); p = NE)] of ZRC-3285 to Eylea®. The proportion of patients who gained more than 15 letters in best corrected visual acuity (BCVA) over 12 weeks and the mean changes in BCVA, choroidal neovascularization (CNV), and central retinal thickness (CRT) were similar in both arms.

Conclusion

Efficacy, immunogenicity, and safety profiles of ZRC-3285 were found to be similar to those of Eylea®.

Trial Registration

Clinical trial Registry of India (CTRI): CTRI/2023/09/057655 [Registered on 14/09/2023].