India Approves First 0.05% Atropine Eye Drop for Myopia Control in Children

Entod Pharmaceuticals has received marketing authorization from the Central Drugs Standard Control Organisation (CDSCO) for India’s first 0.05% atropine eye drop—Myatroo XL—designed to slow the progression of myopia in children aged 6 to 12 years. The approval follows successful completion of Phase 3 clinical trials in India and a regulatory review by the CDSCO.

First-in-Class Approval for Pediatric Myopia Management

Myatroo XL is now the first low-dose atropine eye drop in India officially indicated for pediatric myopia control, marking a significant milestone in the management of childhood vision disorders. It will be available by prescription only and is scheduled for release across India in July 2025.

This approval adds to Entod’s expanding Myatro range, a product line focused on clinically validated, evidence-based pediatric eye care solutions.

Product Features and Availability

Product Name: Myatroo XL
Composition: Atropine Sulphate Ophthalmic Solution 0.05% w/v
Indication: Slows the progression of myopia in children aged 6 to 12 years
Formulation: pH-balanced for enhanced comfort and suitable for long-term daily use

Digital Compliance and Monitoring Support

To improve treatment adherence, Entod will launch a dedicated mobile app—available on Google Play and the App Store—that provides:

       • Daily usage tracking

       • Bottle discarding reminders after one month

       • Doctor appointment reminders

       • Lifestyle and eye care tips to help manage myopia progression

Prescription and Distribution

Myatroo XL will be available by prescription at leading eye hospitals, clinics, and pharmacies across India starting July 2025.