Incorporate sample size proportionate with each indication: CDSCO Panel Tells Sun Pharma on Ranibizumab study

New Delhi: Reviewing the proposal for conducting the Phase IV study of Ranibizumab Solution for Injection 10 mg/mL, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Sun Pharma to incorporate the sample size proportionate with each indication in the study.

This came after the drug major Sun Pharma presented the proposal for permission to conduct a Phase IV study titled “A prospective, multicenter, single-arm, Phase IV study to assess the safety, efficacy, and immunogenicity of Ranibizumab solution for injection 10 mg/mL (rDNA Origin) vide protocol No. ICR/23/004, version No. 2.0 dated 05.04.2024.

Ranibizumab is a recombinant humanized monoclonal antibody and VEGF-A antagonist used for the management of macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration.

Ranibizumab binds to VEGF-A with high affinity as well as its biologically active forms, such as VEGF165, VEGF121, and VEGF110. Notably, VEGF165 is the most predominant isoform in the human eye that promotes ocular neovascularization. VEGF165 enhances vascular permeability, inhibits apoptosis, and causes endothelial-cell mobilization from the bone marrow and differentiation for angiogenesis. Ranibizumab binds to the receptor-binding site of VEGF-A, preventing it from binding to its receptors - VEGFR1 and VEGFR2 - that are expressed on the surface of endothelial cells. Ranibizumab thereby attenuates endothelial cell proliferation, vascular leakage, and new blood vessel formation.

At the recent SEC meeting for Ophthalmology held on 22nd May 2024, the expert panel reviewed the proposal for permission to conduct a Phase IV study titled “A prospective, multicenter, single-arm, Phase IV study to assess the safety, efficacy, and immunogenicity of Ranibizumab solution for injection 10 mg/mL (rDNA Origin) vide protocol No. ICR/23/004, version No. 2.0 dated 05.04.2024."

After detailed deliberation, the committee recommended incorporating the sample size proportionate with each indication in the study.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for further deliberation by the committee.

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