Ophthalmology and therapy · 2026
A Phase III Randomized Trial Comparing Efficacy, Safety, and Immunogenicity of ZRC-3285 vs. Eylea® in Patients with Wet Age-Related Macular Degeneration.
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Bansal Mudit, Singh Punit, Mehta Ruchi K, Laul Rohit Sanjay, Rana Parth, Shah Urmil, Vohra Rajpal, Desai Shachi, Bhomaj Sharad, Patwardhan Sourabh, Manoher Jaishri Murli, Sapar Anjali, Parwal Sandeep, Amabde Ajay Kartik, Shroff Rahul, Natesh Sribhargava, Biswas Rupak Kanti, D Lional Raj, Sinha Bibhuti P, C K Minija, Patel Ekta, Kamble Ashish, Bhende Pramod, Patil Sandeep, Shah Anup, Narula Ritesh, Kumari Bandana, Bathula Lokesh, Kirtane Sandip, Darji Bhargav, Doshi Maulik, Parmar Deven
Аннотация
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].
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].