DCGI gives nod to conduct phase III trial of 0.05% Atropine

“Myopia is a growing concern that causes an abnormal curvature of the cornea or elongation of the eyeball such that light no longer focuses directly on the retina.

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

Being the market leader with the highest market share in low dose atropine (Myatro 0.01%) in India, Entod Pharmaceuticals has now received approval from Drugs Controller General of India (DCGI) to carry out phase 3 trials across India for their 0.05% atropine eye drops.

This higher strength of low-dose atropine eye drops is not available commercially anywhere in the world, and Entod Pharmaceuticals would be the first company to launch this in India subject to a successful demonstration of safety & efficacy in clinical studies.

Myatro 0.01% eye drops are used to treat eye problems like myopia, especially in children, when they can clearly see nearby objects but have problems seeing distant objects.

Low-dose atropine has emerged as an effective approach to slow the progression of myopia in children and has recently garnered a lot of interest from ophthalmologists.

A recent LAMP (Low-Concentration Atropine for Myopia Progression) study published by the American Academy of Ophthalmology (AAO) revealed that the 0.05%, 0.025%, and 0.01% atropine eye drops reduced myopia progression and were well tolerated by children without any adverse effects.

However, out of the three concentrations, 0.05% atropine was the most effective in controlling AL elongation and SE progression over a period of one year.

Speaking about the latest development, the executive director of Entod Pharmaceuticals, Nikkhil K Masurkar said “We have already recruited several clinical research sites across India to start phase 3 trial studies and, hopefully, we will be the first company in the world to get approval for marketing 0.05% atropine eye drops from the DCGI.”

Being market leaders in paediatric ophthalmology medicine, we hope this new therapeutic addition to the low-dose atropine range will allow us to tackle the menace of childhood myopia in India.

Myopia is the most important cause of visual impairment in children and as per a study by AIIMS, 17 per cent of children or 1 out of 6 children in India between the ages of 5-15 years are suffering from myopia.”

“Myopia is a growing concern that causes an abnormal curvature of the cornea or elongation of the eyeball such that light no longer focuses directly on the retina.

Excessive laptop & smartphone screen exposure times, particularly due to online homeschooling during the pandemic, reduced outdoor play and a deceased exposure to sunlight, has considerably increased the incidence of myopia in young children, which could lead to visual complications in later life including glaucoma, early cataract development, retinal detachments, and myopic maculopathy.

“Low-dose atropine eye drops are one of the most viable therapeutic options available to slow down the progression of myopia rapidly and improve a child’s vision,” said Dr Namrata Sharma, general Secretary, All India Ophthalmological Society (AIOS).

She further added, “Atropine treatment is now becoming part of routine clinical practice in India and shows real promise as a treatment for controlling myopia.”

The clinical trials will allow us to further understand how atropine 0.05% can be used effectively with no side effects as a solution for growing myopia concerns not only in India but across the entire world.”

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