First Atropine Eye Drop to Slow Myopia Progression in Children Approved in India

Entod Pharmaceuticals announced it has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for the first 0.05% atropine eye drops (Myatro XL) developed to slow the progression of myopia in children age 6 to 12.

This milestone follows the successful completion of phase 3 clinical trials in India and a review process by Indian drug regulators.

According to an Entod, the treatment will be available by prescription for children diagnosed with myopia. Myatro XL will be the latest addition to Entod's Myatro range, which is focused on evidence-based, clinically validated eye care solutions for children. 

Myatro XL will be available in India in July. 

Product Highlights:

• Composition: Atropine Sulphate Ophthalmic Solution 0.05% w/v
• Indication: For slowing down the progression of myopia in children of age 6 years to 12 years
• Formulation: pH-balanced and comfortable for long-term daily use
• Compliance aid: A dedicated Myatro patient mobile app to be made available on both Google Play and the App Store that would securely monitor compliance of the Myatro range of eye drops, include a 1-month bottle discarding reminder, doctor appointment reminder and lifestyle tips on how to slow down myopia progression.
• Availability: To be made available by prescription at leading eye hospitals, clinics, and pharmacies across India from July 2025