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).
Last year, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had given its nod to pharma major Lupin for marketing Ranibizumab with conditions that the specifications of the drug should be equivalent to the reference product and the firm should submit a Phase IV clinical trial protocol within three months of the grant of marketing authorization.
Also Read:Lupin gets CDSCO committee approval for marketing Ranibizumab
In accordance with the above, at the recent SEC meeting for Ophthalmology held on September 22, 2022, Pharma major Lupin has 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.
The expert panel reviewed the Phase IV clinical trial protocol of Ranibizumab for intravitreal injection.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV study as per the protocol.
