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Sun Pharma Receives CDSCO Panel Nod for Aflibercept Phase III Study in Wet AMD

• Sun Pharmaceutical Industries has received approval from the CDSCO panel to conduct a Phase III clinical trial of Aflibercept injection for neovascular age-related macular degeneration. • The study will evaluate the efficacy, safety, and immunogenicity of Sun Pharma's Aflibercept against a reference biologic in patients with wet AMD. • The CDSCO panel has mandated a 6-month follow-up duration and the use of Ranibizumab for standard care treatment during the study. • All primary and secondary efficacy endpoints must be evaluated at 6 months (24 weeks), in addition to safety assessments, as per the CDSCO's requirements.

Sun Pharmaceutical Industries has been granted approval by the Subject Expert Committee (SEC) under the Central Drug Standard Control Organization (CDSCO) to proceed with a Phase III clinical study of Aflibercept injection (40 mg/mL, 0.278 mL/vial) for patients suffering from neovascular age-related macular degeneration (wet AMD).
The approval is for a prospective, multi-center, double-blind, active-controlled, parallel-group Phase III study designed to compare the efficacy, safety, and immunogenicity of Sun Pharma’s Aflibercept with a reference biologic in patients with wet AMD. The study protocol is identified as ICR/24/006, Version 1.0, dated June 18, 2024.
The CDSCO panel's approval is contingent upon specific conditions. The follow-up duration of the study must be extended to 6 months. If necessary, based on observations during the follow-up period, subjects should receive a subsequent dose of the study drug. Furthermore, all proposed primary and secondary efficacy endpoints must be evaluated at the 6-month (24-week) mark, in addition to the ongoing safety assessments.

Standard Care Treatment

The panel specified that Ranibizumab should be used, if required, along with other medications for standard care treatment during the trial.
Aflibercept functions as a vascular endothelial growth factor (VEGF) inhibitor. It is used in the treatment of neovascular (wet) age-related macular degeneration (AMD), various types of macular edema, diabetic retinopathy, and metastatic colorectal cancer. Aflibercept is a recombinant protein composed of the binding domains of two human vascular endothelial growth factor (VEGF) receptors, VEGFR1 and VEGFR2, fused with the Fc region of human immunoglobulin gamma 1 (IgG1).
During the SEC meeting for ophthalmology on September 19, 2024, the expert panel reviewed Sun Pharmaceutical Industries' protocol for the Phase III clinical study of Aflibercept injection. Following detailed deliberation, the committee recommended the study's conduct, subject to the aforementioned protocol changes, and requested the submission of a revised protocol to CDSCO for evaluation.
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Reference News

[1]
Sun Pharmaceutical Industry gets CDSCO Panel nod to study Aflibercept Injection
medicaldialogues.in · Oct 6, 2024

SEC approves Sun Pharma's Phase III study of Aflibercept injection for neovascular AMD, subject to 6-month follow-up and...

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