Lupin Ranibizumab intravitreal injection gets CDSCO Panel nod for Phase IV study
New Delhi: Pharmaceuticals major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) for a Phase IV trial of recombinant humanised monoclonal antibody Ranibizumab, which is used to treat certain serious eye conditions such as age-related macular degeneration, macular edema, and diabetic retinopathy.
This came after the firm presented the Phase IV clinical trial protocol titled "A prospective, multi-center, single arm, open label, Phase IV study to evaluate safety and efficacy of RaniEyes in real world clinical practice" vide Protocol Number: LRP/LUBT010/2021/006 Date:25 January 2022.
RaniEyes is Ranibizumab for intravitreal injection. This brand name RANIEYES is applied by Lupin Limited.
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use and it is used in the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
It acts by binding to human vascular endothelial growth factor A, resulting in suppression of the biologic activity of human vascular endothelial growth factor A (VEGF-A).
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