CDSCO Approves Entod Pharma's Myopia-control Eye Drop for Children

The Central Drugs Standard Control Organization (CDSCO) has granted marketing authorization to Entod Pharmaceuticals, a multinational research-driven ophthalmic firm, for a novel ocular formulation designed to prevent the progression of myopia in children between the ages of 6 and 12. This is the first time an eye medication with this special therapeutic strength for pediatric use has received regulatory approval worldwide.

This milestone comes after a thorough approval process by India's top pharma authority and the successful conclusion of phase 3 clinical trials in India. After an evaluation by an eye doctor, children with myopia will only be able to receive the treatment with a prescription from a qualified medical practitioner.

With more than 47 years of expertise creating cutting-edge eye care products, Entod Pharmaceuticals is a multinational, research-driven ophthalmic business. With operations in over 67 nations, Entod is committed to further its "Make in India for the World" objective by providing high-quality, reasonably priced, and easily accessible eye care.

Dr. Mohita Sharma, medical director at Tirupati Eye Centre & Research Institute and a principal investigator in the Indian clinical study says, "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, Nikkhil K Masurkar, CEO of Entod Pharmaceuticals, states, "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."