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Intas Pharmaceuticals Gets CDSCO Panel Nod To study Bevacizumab Solution for Injection

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-12T17:45:27+05:30  |  Updated On 12 March 2025 5:45 PM IST
Intas Gets SEC Nod to Import, Market Anti-Cancer Drug Serplulimab, Phase IV Trial Mandated
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New Delhi: Intas Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase II/III clinical trial of Bevacizumab Solution for Injection 25 mg/mL (Vial 5.75mg/0.23 mL) in participants with Neovascular (wet) Age Related Macular Degeneration.

However, this approval is subject to the condition that the firm should include the provision for standard of care to the study subjects for the other eye if required during the study in the protocol. In addition, the expert panel opined that the firm should submit the results of the Phase II clinical study to CDSCO after completion of the study.

This came after Intas Pharmaceutical presented the protocol to conduct a Phase II/III clinical trial titled 'A Phase 2/3, Randomized, Double-Masked, Parallel Group, Multicentre, Comparative Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age-Related Macular Degeneration (Protocol No. 0235-24A; Version 2.0 dated 10 Sep 2024).

Age-related macular degeneration (AMD) is an eye disease that damages the retina and causes blurred vision in the center of your field of vision.

Bevacizumab injection products are in a class of medications called antiangiogenic agents. Bevacizumab acts by selectively binding circulating VEGF, thereby inhibiting the binding of VEGF to its cell surface receptors. This inhibition leads to a reduction in the microvascular growth of tumor blood vessels and thus limits the blood supply to tumor tissues.

At the recent SEC meeting for ophthalmology held on February 25, 2025, the expert panel reviewed the protocol for conducting a Phase II/III clinical trial titled 'A Phase 2/3, Randomized, Double-Masked, Parallel Group, Multicentre, Comparative Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age-Related Macular Degeneration.”

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase II/III study with the following conditions:.

1. The protocol should include provision for a standard of care for the study subjects for the other eye if required during the study.

2. The firm should submit the results of the Phase II clinical study to CDSCO after completion of the study.

Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO for evaluation.

Also Read: Hetero Labs Gets CDSCO Panel Nod To study Semaglutide Injection for Type 2 Diabetes Mellitus

intas pharmacdscobevacizumabneovascular age-related macular degenerationIntas Pharmaceutical
Dr. Divya Colin
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

    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

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