Entod Pharma gets DCGI nod for phase 3 trials of Atropine eye drops
"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" said Dr Namrata Sharma, Hony. General Secretary, All India Ophthalmological Society (AIOS);
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Mumbai: ENTOD Pharmaceuticals has recently announced that the company has received the DCGI approval to carry out phase 3 trials across India for their 0.05% atropine eye drops.
According to the company, 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 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. "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," the company noted.
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 without any adverse effect by children. 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.
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