Biocon Gets CDSCO Panel Nod to Import Aflibercept Injection for Eye Disorders, Phase IV Trial Mandated
New Delhi: Biocon Biologics Limited has received recommendations from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market Aflibercept Injection (40 mg/mL in vial form) in India for multiple ophthalmic indications.
The company presented its proposal for grant of marketing authorization for Aflibercept solution for injection (40 mg/ml) based on the results of a global clinical trial in which India was a participating country, specifically for Diabetic Macular Oedema (DME).
According to the committee’s minutes, the proposed indications include:
Neovascular (wet) age-related macular degeneration (AMD),
Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),
Visual impairment due to diabetic macular oedema (DME),
Visual impairment due to myopic choroidal neovascularisation.
After reviewing the submission, the SEC noted:
“After detailed deliberation, the committee recommended for grant of permission to import and market the drug product Aflibercept solution for injection in a vial (40 mg/ml) for applied indications with a condition to conduct Phase IV study in India for indications of macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), myopic choroidal neovascularization (CNV) and neovascular (wet) age-related macular degeneration (AMD) with statistically significant sample size for each indication.”
The regulator further directed that, “Accordingly, firm shall submit Phase IV Clinical Trial protocol to CDSCO within 03 months of grant of marketing authorization permission.”
Aflibercept, an anti-VEGF therapy, is widely used worldwide to treat retinal disorders associated with abnormal blood vessel growth and leakage in the eye, which are among the leading causes of vision loss.
The recommendations were made during the SEC (Ophthalmology) meeting held on August 26, 2025.
