Zydus Lifescience Gets CDSCO Panel Nod to Study Aflibercept
New Delhi: The drug major Zydus Lifescience has got the green signal from the Subject Expert Committee SEC functional under Central Drug Standard Control Organization CDSCO to conduct a Phase III, randomized, double-blind, parallel-group, multi-centre study to compare the efficacy, safety and immunogenicity between test Aflibercept and Eylea in patients with neovascular (Wet) age-related macular degeneration (AMD).
This approval, however, came with some modifications to the provided procedure, which specified that Sr. No. 09 in the inclusion criterion needed to be made specifically with regard to female subjects.
This came after the firm presented the protocol to conduct a Phase III clinical trial titled “A Phase III, randomized, double-blind, parallel-group, multi-centre study to compare the efficacy, safety and immunogenicity between test Aflibercept and Eylea in patients with neovascular (Wet) age-related macular degeneration (AMD)” as per protocol No. AFLI.22.001 version 01.
Aflibercept injection is in a class of medications called vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonists. It works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss in people with certain eye conditions.
Aflibercept injection is used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities). It is also used to treat macular oedema after retinal vein occlusion (an eye disease caused by blockage of blood flow from the eye that leads to blurry vision and vision loss), diabetic macular oedema (an eye disease caused by diabetes that can lead to vision loss), and diabetic retinopathy (damage to the eyes caused by diabetes). Aflibercept injection is also used to treat retinopathy of prematurity (ROP; an eye disease that occurs in premature infants that can lead to vision loss and blindness).
Aflibercept is a humanized recombinant fusion protein that functions as a vascular endothelial growth factor (VEGF) inhibitor, thus preventing choroidal neovascularization. The VEGF signalling pathway is implicated in the induction of gene expression, regulation of vascular permeability, proliferation, and survival.
At the recent SEC meeting for Ophthalmology held on 25th May 2023, the expert panel reviewed the protocol for the conduct of a Phase III clinical trial titled “A Phase III, randomized, double-blind, parallel-group, multi-centre study to compare the efficacy, safety and immunogenicity between test Aflibercept and Eylea in patients with neovascular (Wet) age-related macular degeneration (AMD)” as per protocol No. AFLI.22.001 version 01.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase III clinical trial with the following changes in the presented protocol.
1. In the inclusion criteria, Sr. No. 09 needs to be clearly defined with respect to female participants. The wording should be that women who have attained menopause should be included instead of a female participant being eligible to participate if she is not pregnant or breastfeeding, etc.
2. The firm should provide a standard of care to the study subject for the other eye which is not under study during the trial.
Accordingly, the committee suggested that the firm should submit a revised protocol to CDSCO.
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