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.
Commenting on the CDSCO’s marketing approval, Mr. Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, stated, "This is a proud moment for our research and regulatory teams. Securing regulatory approval for this unique treatment strength—the first of its kind globally—underscores our continued commitment to innovation in eye care. With myopia rates in India rising from 4% in 1999 to nearly 25% today, and projections suggesting that by 2050 one in two children could be affected, the need for such a therapy has never been more urgent.
