India approves first-of-its-kind pediatric eyedrop as myopia rates surge
In a significant development for paediatric eye care, India has become the first country to approve a new formulation of eye drops specifically designed to slow the progression of myopia in children. The approval, granted by the Central Drugs Standard Control Organisation (CDSCO), marks a global first for this strength of treatment aimed exclusively at children aged 6 to 12.
The eye drops, developed by Entod Pharmaceuticals, will be available by prescription only, and can be used only after a thorough assessment by an eye specialist confirms that a child is suitable for the therapy. This move comes as childhood myopia continues to rise sharply in India, prompting concerns among ophthalmologists and public health experts alike.
Related: Asia’s myopia epidemic and the race to save our children’s vision
While myopia—commonly known as near-sightedness—has long been manageable with glasses, contact lenses, or surgery, the newly approved eye drops represent a shift toward proactive management aimed at slowing its progression, rather than simply correcting the symptoms.
Medical experts involved in the Indian clinical trials say the timing of the approval is crucial. Dr. Mohita Sharma, who oversaw part of the Phase 3 trials, noted that the growing reliance on screens and extended near-work activities—such as reading or playing on tablets—is fueling a myopia epidemic among Indian children. She emphasized that such behavioral patterns are not only contributing to early onset but also to more rapid progression of the condition.
According to Dr. Sharma, unchecked myopia can lead to complications later in life, including a higher risk of retinal detachment, glaucoma, and even vision loss. She believes this new treatment provides a vital tool to address these long-term risks by intervening early in the condition’s development.
The regulatory green light came after the drug successfully cleared advanced clinical trials in India. The data, reviewed through a stringent approval process, showed the drops were effective in slowing myopia progression in children without significant side effects.
Entod Pharmaceuticals, the Mumbai-based company behind the product, says the launch reflects a broader strategy to innovate within ophthalmology and to meet emerging needs in vision care. CEO Nikkhil K Masurkar pointed out that myopia in India has increased more than fivefold over the past 25 years. He noted that this surge is no longer a concern limited to urban populations, but one that is expanding rapidly across rural areas as well.
Projections for the future are even more alarming. Some studies estimate that by 2050, as much as 50 percent of India’s child population could be affected by myopia. This trend mirrors global patterns, particularly in East and Southeast Asia, where densely packed urban living and academic pressure have already driven childhood myopia rates to unprecedented levels.
What sets India apart now is its readiness to approve a targeted pharmaceutical response ahead of many wealthier nations. For Entod, it represents both a scientific and commercial milestone. For India’s healthcare system, it signals a shift toward preemptive paediatric interventions, rather than simply managing disease outcomes.
The treatment is expected to become available in the coming months, and while its long-term impact on myopia rates will take years to assess, doctors and policymakers alike are hailing the move as a necessary step forward.
Category: Pharmaceuticals
