ENTOD Pharma receives DCGI approval for phase 3 trials of its myopia eye drop

ENTOD Pharmaceuticals on Tuesday announced that it has received approval from Drug Controller General of India (DCGI) to carry out phase 3 trials across the country for their 0.05 per cent atropine eye drops used to treat eye problems.

Maharashtra-based pharmaceutical company has the highest market share in low dose atropine -- MYATRO 0.01 per cent eye drops -- is used to treat eye problems like myopia, especially in children when a child can clearly see nearby objects but has problems seeing distant objects.

The company in a statement said that 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 and efficacy in clinical studies.

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 per cent, 0.025 per cent, and 0.01 per cent atropine eye drops reduced myopia progression and were well tolerated without any adverse effect by children. However, out of the three concentrations, 0.05 per cent atropine was the most effective in controlling AL elongation and SE progression over one year, the company said.

“We have already recruited several clinical research sites across India to start phase 3 trial studies and hopefully, we should be the first company in the world to get approval for marketing 0.05 per cent atropine eye drops from the Drug Controller General of India (DCGI),” Nikkhil K Masurkar, Executive Director of ENTOD Pharmaceuticals, said.

“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,” he said.

Doctors state that 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 and smartphone screen exposure times particularly due to online homeschooling during the pandemic, reduced outdoor play and a decreased exposure to sunlight has considerably increased the incidence of myopia in younger children which could lead to visual complications in later life including glaucoma, early cataract development, retinal detachments and myopic maculopathy,” said Dr Namrata Sharma, General Secretary, All India Ophthalmological Society (AIOS).

“Low-Dose Atropine eye drops is one of the most viable therapeutic option available to slow down the progression of myopia rapidly and improve a child's vision” added Sharma.

She further added “Atropine treatment is now become 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 the atropine 0.05 per cent can be used effectively with no side effects as a solution for growing myopia concerns not only in India but across the entire world,” she said.