CDSCO nod to ENTOD Pharma new eye drop to slow Myopia progression in children
CDSCO granted marketing authorisation following the successful completion of a Phase 3 clinical trial conducted across 11 sites in India.;
Mumbai: ENTOD Pharmaceuticals has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for a new eye drop medicine developed to slow the progression of myopia in children aged 6 to 12 years.
"This historic milestone marks the first global regulatory approval for this unique treatment strength, and also highlights the growing impact & leadership of Indian innovation in the pharmaceutical sector The introduction of this pioneering therapy, developed and trialed by an Indian company, is poised to make a transformative impact on paediatric eye health in the country," the Company claimed.
The treatment will be available strictly by prescription from a registered medical practitioner for children diagnosed with myopia, following an evaluation by an eye doctor.
The Central Drugs Standard Control Organisation (CDSCO) granted marketing authorisation following the successful completion of a Phase 3 clinical trial conducted across 11 sites in India. The approval comes after a rigorous evaluation process by India’s apex drug regulator, further underscoring the robustness and credibility of the scientific data generated by ENTOD Pharmaceuticals’ research team.
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