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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-09T17:30:19+05:30 | Updated On 9 Nov 2024 5:30 PM IST

CDSCO Panel Nod to Sun Pharma for Ranibizumab Study

New Delhi: The drug major Sun Pharmaceutical Industries has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase IV study of Ranibizumab Solution for Injection 10 mg/ml

This came after Sun Pharmaceutical Industries presented the proposal for conducting the phase IV study in the approved indications vide revised protocol ICR 23/004, Version No. 3.0dated 09.07.2024.

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 is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. It is used to treat eye conditions such as diabetic retinopathy and macular edema.

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.

Also Read: CDSCO Panel Approves Pfizer Protocol Amendment proposal to study anti-cancer drug Elranatamab

Sun Pharmaceutical Industriescdscoranibizumabphase 4 trialsun pharma

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751