Mumbai-based ENTOD Pharmaceuticals has received marketing authorization from India's Central Drugs Standard Control Organisation (CDSCO) for its 0.05% atropine eye drops (Myatro XL), designed to slow myopia progression in children aged 6 to 12 years. This approval represents the first global regulatory clearance for this specific treatment strength of atropine for pediatric myopia management.
The prescription-only medication will be available in India beginning July 2025, joining ENTOD's existing Myatro product line, which currently includes a 0.01% atropine formulation for children aged 4 to 14 years.
Clinical Evidence Supporting Approval
The CDSCO approval follows successful completion of Phase 3 clinical trials conducted across 11 sites in India. The multicenter, randomized, double-blinded, parallel-group comparative study enrolled 190 children between 6 and 12 years with diagnosed myopia.
Participants were divided into two treatment arms: one receiving atropine sulfate 0.05% and the other atropine sulfate 0.01%, administered as one drop daily (preferably at night) in each eye for 12 months.
The primary endpoint measured mean change in spherical equivalent refractive error from baseline to 12 months, while secondary endpoints assessed the proportion of participants showing less than 0.50 D of myopia progression, changes in ocular axial length, pupil size, accommodation amplitude, and visual acuity.
Results demonstrated statistically significant differences between the treatment groups:
- Right eye spherical equivalent change: -0.13 ± 0.62 D with 0.05% atropine vs. -0.33 ± 0.80 D with 0.01% atropine (P=0.0493)
- Left eye spherical equivalent change: -0.15 ± 0.71 D with 0.05% atropine vs. -0.34 ± 0.88 D with 0.01% atropine
Additionally, a higher percentage of participants using 0.05% atropine showed less than 0.50 D myopia progression compared to those using 0.01% concentration (76.09% vs. 65.56% for right eye; 71.74% vs. 70.00% for left eye).
The 0.05% formulation also demonstrated superior control of axial length changes in both eyes compared to the 0.01% concentration. Importantly, the treatment was well-tolerated with no serious adverse effects reported during the trial.
Product Features and Patient Support
The atropine sulfate ophthalmic solution 0.05% is pH-balanced and formulated for long-term, daily use in pediatric patients. To support treatment adherence, ENTOD will launch a dedicated Myatro mobile application available on both Google Play and Apple App Store.
The patient-centric app will provide bottle discard reminders, follow-up appointment notifications, and secure monitoring capabilities for patients using products in the Myatro line.
Addressing a Growing Public Health Concern
Dr. Mohita Sharma, Medical Director at Tirupati Eye Centre & Research Institute and a principal investigator in the clinical study, emphasized the significance of this development: "Myopia, or nearsightedness, is a growing public health concern, especially among school-aged children with increased exposure to prolonged near work and digital screens. This new treatment is a significant advancement in pediatric eye care, offering a means to effectively slow the progression of myopia."
The approval comes at a critical time as myopia rates in India have risen dramatically from 4% in 1999 to nearly 25% today. Projections suggest that by 2050, one in two children could be affected by the condition.
Company Perspective
Nikkhil K Masurkar, CEO of ENTOD Pharmaceuticals, highlighted the achievement: "This is a proud moment for our research and regulatory teams. Securing regulatory approval for this unique treatment strength—the first of its kind globally—underscores our continued commitment to innovation in eye care."
ENTOD Pharmaceuticals, with over 47 years of experience in developing ophthalmic solutions, maintains a presence in more than 67 countries and continues to advance its "Make in India for the World" mission by delivering accessible and affordable eye treatments.
Clinical Implications
The approval of 0.05% atropine eye drops represents an important addition to the therapeutic arsenal for managing childhood myopia. The higher efficacy compared to the 0.01% concentration, combined with a favorable safety profile, offers eye care professionals a valuable option for slowing myopia progression in pediatric patients.
Early intervention in myopia management is crucial for preventing complications associated with high myopia later in life, including increased risks of retinal detachment, glaucoma, and myopic maculopathy.
