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