ENTOD Pharmaceuticals today announced that it has been granted marketing authorisation by the Central Drugs Standard Control Organisation (CDSCO) for a new eye drop formulation specifically designed to slow the progression of myopia (nearsightedness) in children aged 6 to 12 years. This landmark achievement marks the first global regulatory approval for the unique treatment strength of an eye medicine tailored for pediatric use.
The CDSCO approval follows the successful completion of Phase 3 clinical trials conducted in India and a thorough evaluation by the country’s apex drug regulator. The innovative treatment will be available strictly via prescription from a registered medical practitioner for children diagnosed with myopia, after a comprehensive evaluation by an eye doctor to determine their suitability.
Dr. Mohita Sharma, Medical Director at Tirupati Eye Centre & Research Institute and a principal investigator in the Indian clinical study, emphasised the significance of this development, stating, “Myopia is increasingly prevalent among school-aged children due to factors like increased near work and digital screen time. This new treatment represents a significant step forward in pediatric eye care, offering an effective means to slow down myopia progression following a detailed eye examination. This can help in preventing the development of high myopia and its associated complications, ultimately leading to improved long-term visual outcomes for children.”
Mr. Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, expressed his pride in this achievement, commenting, “This CDSCO approval is a testament to the dedication and innovation of our research and regulatory teams. Securing the first global regulatory approval for this specific treatment strength underscores our unwavering commitment to advancing eye care. With the alarming rise in myopia prevalence in India, from 4% in 1999 to nearly 25% today, and projections indicating that half of all children could be affected by 2050, the availability of such a therapy is critically important.”
ENTOD Pharmaceuticals is a globally recognised, research-driven ophthalmic company with over four decades of experience in developing cutting-edge eye care solutions. With a footprint spanning more than 67 countries, ENTOD continues to drive its “Make in India for the World” mission by providing accessible, affordable, and world-class eye treatments.
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