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Listen to Story India's drug regulator has given the green light to a new eye medicine that can slow the progression of myopia, also known as near-sightedness, in children aged between 6 and 12 years. The Central Drugs Standard Control Organisation (CDSCO) has granted marketing approval to Entod Pharmaceuticals for a new formulation of eye drops, marking the first global regulatory approval for this specific strength designed exclusively for paediatric use. The treatment will be available only on prescription, and only after an eye specialist evaluates and confirms that a child is suitable for the therapy.
WHAT IS MYOPIA? Myopia is the clinical name for near-sightedness, meaning that while one can clearly see objects nearby, they have difficulty seeing objects farther away. The problem is very common, not just in India but across the globe. Not getting yourself treated can affect your vision in the long run, leading to headaches, eye strain and squinting.
The causes of myopia are not specific as it is a mix of hereditary factors and lifestyle choices. Working very close to your eyes and looking into an object for a long time can result in myopia. It can be managed with powered glasses, contact lenses or surgery.
The causes of myopia are not specific as it is a mix of hereditary factors and lifestyle choices. (Photo: Getty Images) One of the principal investigators of the Indian clinical trial, Dr. Mohita Sharma, Medical Director at Tirupati Eye Centre & Research Institute, said that the approval is timely, as India is seeing a rapid rise in cases of childhood myopia.
He added that children are spending more time on screens and doing activities that require them to focus on a single object for a long time, both of which are linked to worsening eyesight. "Myopia is becoming a serious public health concern. This new treatment is a breakthrough in paediatric eye care.
It can help slow down the progression of myopia and prevent future complications related to high myopia," said Dr Sharma. The drug was cleared after successful Phase 3 clinical trials in India and a rigorous regulatory process. According to Entod Pharmaceuticals, myopia rates in India have grown significantly over the past two decades, from 4% in 1999 to nearly 25% today.
Some studies predict that by 2050, one in every two children in the country could be affected. "This approval reflects our commitment to innovation and to addressing growing challenges in eye health," said Nikkhil K Masurkar, CEO of Entod..
