Intas Pharmaceutical gets CDSCO Panel nod to study Aflibercept Solution for Injection 40 mg/ml in Vial
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional Central Drug Standard Control Organisation (CDSCO) for Phase III study to evaluate the efficacy, safety, and immunogenicity of Aflibercept Intravitreal Injection and Eylea (Aflibercept) Intravitreal Injection in Patients with Diabetic Macular Oedema (DME). However, this nod is subject to conditions in relation to the inclusion criteria, number of evaluable subjects, and etc.
This came after the firm presented the proposal for the conduct of a Phase III clinical trial titled “A Phase-3,Double-Masked, Two-Arm, Multiple Dose, Parallel Group, Randomized, Multicentre, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Aflibercept Intravitreal Injection and Eylea (Aflibercept) Intravitreal Injection in Patients with Diabetic Macular Oedema (DME)” vide Protocol 0252-24 Version: 1.0 dated 11.07.2024.
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 November 21, 2024, the expert panel reviewed the proposal for the conduct of Phase III clinical trial titled “A Phase-3, Double-Masked, Two-Arm, Multiple Dose, Parallel Group, Randomized, Multicentre, Active- Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Aflibercept Intravitreal Injection and Eylea (Aflibercept) Intravitreal Injection in Patients with Diabetic Macular Oedema (DME)” .
After detailed deliberation, the committee recommended the firm conduct the Phase III study as per presented protocol with the following conditions:
1. The acceptable fasting blood sugar and postprandial blood sugar levels should be clearly defined in the inclusion criteria.
2. The number of evaluable subjects in the test arm should be at least 100.
3. Subjects should be discontinued from the study when there is any worsening condition/adverse event in the treatment eye. Subsequently, the patients should be provided with a standard of care.
4. Treatment of the other eye as per standard of care should be included in the protocol.
Accordingly, the expert panel suggested the firm that the revised protocol should be submitted to CDSCO for evaluation.
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