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....
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.
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).
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.
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