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  • CDSCO nod to ENTOD...

CDSCO nod to ENTOD Pharma new eye drop to slow Myopia progression in children

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-28T16:00:20+05:30  |  Updated On 28 April 2025 4:00 PM IST
CDSCO nod to ENTOD Pharma new eye drop to slow Myopia progression in children
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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.

Dr. Mohita Sharma, Medical Director at Tirupati Eye Centre & Research Institute and a principal investigator in the Indian clinical study, commented, "Myopia, or near sightedness, is a growing public health concern, especially among school-aged children with increased exposure to prolonged near work and digital screens. This new treatment is a significant advancement in paediatric eye care, offering a means to effectively slow the progression of myopia after detailed examination to determine the child's suitability for this treatment, and to help prevent complications associated with high myopia and improve long-term visual outcomes."

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.

entod pharmaentod pharma newsCDSCOmyopiaeye drop
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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