ENTOD Pharmaceuticals has announced that it has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for a new ophthalmic formulation designed to slow the progression of myopia in children aged 6 to 12 years. This marks the first global regulatory approval for this specific treatment strength in paediatric eye care.
The approval follows the completion of Phase 3 clinical trials conducted in India and a detailed review process by the national drug regulator. The treatment will be available only through prescription from registered medical practitioners and will be indicated for children diagnosed with myopia after a comprehensive evaluation by an ophthalmologist.
Dr Mohita Sharma, Medical Director at Tirupati Eye Centre & Research Institute and a principal investigator in the clinical study, said, “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.”
Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, said, “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 per cent in 1999 to nearly 25 per cent 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 Pharmaceuticals is a research-driven ophthalmic company with over 47 years of experience. The company operates in more than 67 countries and continues its “Make in India for the World” initiative by developing and distributing prescription eye care treatments.