Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study Ranibizumab Solution for Injection

Ranibizumab binds to VEGF-A with high affinity as well as its biologically active forms, such as VEGF165, VEGF121, and VEGF110.4 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 24th October 2024, the expert panel reviewed the proposal for the conduct of Phase IV study in the approved indications vide revised protocol ICR 23/004, Version No. 3.0 dated 09.07.2024.

After detailed deliberation, the committee granted the approval to conduct the study as per revised protocol presented by the firm.

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