Entod Pharma gets DCGI nod to carry out phase-III trial of Atropine eye drops

Subject to a successful demonstration of safety and efficacy in clinical studies, Entod Pharma would be the first company to launch this in India.

Entod Pharma has got the approval to carry out phase-III trials across India for their 0.05% Atropine eye drops from the Drugs Controller General of India (DCGI). Subject to a successful demonstration of safety and efficacy in clinical studies, Entod Pharma would be the first company to launch this in India.

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 Low-Concentration Atropine for Myopia Progression (LAMP) 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.

clinical trialDCGI nodENTOD Pharma
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  • Vivek Hattangadi

    Wow! That’s a great breakthrough to reduce the progression of myopia.

    Congratulations Team Entod