Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study Ranibizumab Solution for Injection
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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.