IQVIA Gets CDSCO Panel Nod To Study AVT06 biosimilar candidate to Eylea

Written by Dr. Divya Colin Published On 2022-10-09T13:40:22+05:30 | Updated On 9 Oct 2022 1:40 PM IST

IQVIA Gets CDSCO Panel Nod To Study AVT06 biosimilar candidate to Eylea

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the major clinical research organization IQVIA for conducting the proposed Phase III clinical trial of AVT06 (Proposed Biosimilar to Eylea) for the treatment of retinal vascular diseases, a major cause of visual impairment and blindness.

However. the approval came with condition that if the subjects develop Choroidal neovascularization (CNV) in the fellow eye then it should be managed as per the standard of care and the cost of the same should be borne by the sponsor.

This arose when the firm presented the proposed Phase III clinical trial protocol no. AVT06-GL-C01, Version 2.0, dated December 21, 2022, before the committee.

AVT06 is a recombinant fusion protein and a biosimilar candidate to Eylea (aflibercept). Eylea is a prescription medicine used to treat the symptoms of Macular Degeneration, Diabetic Retinopathy and Macular Edema.

Aflibercept, as an ophthalmic agent, is used in the treatment of macular edema following Central Retinal Vein Occlusion (CRVO) and neovascular Age-Related Macular Degeneration (AMD).

Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.

Also Read:Aflibercept increases retinal nonperfusion in eyes with proliferative diabetic retinopathy: Study

It acts as a decoy receptor for the ligands, vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PIGF). It prevents these ligands to binding to endothelial receptors, VEGFR-1 and VEGFR-2, to suppress neovascularization and decrease vascular permeability. This ultimately will slow vision loss or the progression of metastatic colorectal cancer.

Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.

At the recent SEC meeting for Ophthalmology held on September 22, 2022, the expert panel reviewed Phase III clinical trial protocol no. AVT06-GL-C01, Version 2.0, dated December 21, 2022, presented by the major clinical research organization IQVIA.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as per the protocol with a condition that if the subjects develop CNV in the fellow eye then it should be managed as per the standard of care and the cost of the same should be borne by the sponsor.

Also Read:Bayer Eylea approved in Japan for treatment of preterm infants with retinopathy of prematurity

IQVIAAVT06eyleaafliberceptcdsco panelphase 3 trialretinal vascular disease

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.