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

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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