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

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.