Sun Pharmaceutical Industry gets CDSCO Panel nod to study Aflibercept Injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major Sun Pharmaceutical Industries to conduct the Phase III clinical study of Aflibercept injection 40 mg/mL, 0.278 mL/vial in patients with neovascular age-related macular degeneration.
This came after the firm presented the protocol to conduct a Phase III clinical study of Aflibercept injection at 40 mg/mL and 0.278 mL/vial in patients with neovascular age-related macular degeneration titled "A Prospective, Multicenter, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Compare the Efficacy, Safety and Immunogenicity of Sun’s Aflibercept with Reference Biologic in Patients with Neovascular Age-Related Macular degeneration (wet AMD)" vide Protocol No. ICR/24/006, Version No. 1.0; dated 18.6.2024.
However, the nod is subject to the condition that the follow-up duration of the study should be increased to 6 months and a subsequent dose of the study drug should be provided to the study subjects if required based on the observation during the follow-up study duration.
Furthermore, the condition added that all the proposed primary and secondary efficacy endpoints should be evaluated at 6 months (24 weeks) in addition to the safety.
In addition to the above, the condition stated that for the standard care treatment, Ranibizumab should be used if required along with other medications.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD), various types of macular edema and diabetic retinopathy, and metastatic colorectal cancer.
Aflibercept is a recombinant protein composed of the binding domains of two human vascular endothelial growth factor (VEGF) receptors, VEGFR1 and VEGFR2, fused with the Fc region of human immunoglobulin gamma 1 (IgG1).
At the recent SEC meeting for ophthalmology held on September 19, 2024, the expert panel reviewed the protocol for conducting a Phase III clinical study of aflibercept injection, which was submitted by the drug major Sun Pharmaceutical Industries.
After detailed deliberation, the committee recommended the conduct of the proposed Phase III study with the following changes in the protocol:
1. Follow-up duration of the study should be increased to 6 months and subsequent dose of study drug should be provided to the study subjects if required based on the observation during the follow up study duration. All the proposed primary and secondary efficacy endpoints should be evaluated at 6 months (24 weeks) in addition to the safety.
2. For the standard care treatment, Ranibizumab should be used if required along with other medications.
Accordingly, the expert panel stated the firm should submit the revised protocol to CDSCO for evaluation.
Also Read: CDSCO becomes Affiliate Member of International Medical Device Regulators Forum
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