ENTOD Pharmaceuticals announces CDSCO approval of 0.05% atropine drops in India

The atropine sulphate ophthalmic solution 0.05% is pH-balanced and indicated for long-term, daily use by pediatric patients.

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Mumbai-based ENTOD Pharmaceuticals announced its 0.05% atropine eye drops (Myatro XL) have received marketing authorization from India's Central Drugs Standard Control Organization (CDSCO). The atropine eye drops are designed to slow myopia progression in children ages 6 to 12, the company said in a press release.¹

The 0.05% atropine drops will be available by prescription in India beginning in July 2025, ENTOD Pharmaceuticals said in a press release. Myatro XL joins ENTOD’s Myatro line.

The atropine sulphate ophthalmic solution 0.05% is pH-balanced and indicated for long-term, daily use by pediatric patients. In order to aid compliance and adherence, a dedicated MYATRO mobile app will become available in the Google Play and Apple App Store upon launch. The patient-centric app will provide bottle discard reminders, follow-up appointment reminders, and other means of secure monitoring for compliance with the MYATRO XL drops and other products in the MYATRO line. Currently, the MYATRO line includes 0.01% atropine drops; the lower-volume solution is available for patients aged 4 to 14 with pediatric myopia.

Phase 3 ARM study shows efficacy, safety of atropine 0.05%

The marketing authorization comes on the heels of successful completion of the phase 3 ARM study in India.² Children between 6 and 12 years old with spherical equivalent refractive (SER) error between -2.00 diopters (D) and -6.00 D with documented myopia progression of more than 0.75 D in the previous year were administered one drop of atropine 0.05% in both eyes before bed for 1 year. The primary end points were change in the rate of myopia progression (measured in D change per year) and change in SER and axial length.

40 participants enrolled with a mean age of 8.5 years old ± 2.2 years. One year prior to treatment, the mean SER was -3.53 ± 078 D. Mean baseline SER was reported to be -4.58 ±1.03 D, and the investigators noted the increase to 4.98 ± 0.97 D at the 1-year followup, which is a 62% reduction in the rate of myopia progression compared with the rate of progression before treatment with atropine 0.05%. Mean axial length at baseline was 24.98 ± 2.43 mm, which increased to 25.21 ± 2.32 mm at 1-year followup. No significant correlation between axial length and SER changes could be found (P = 0.063).

Response to treatment was not dependent on age, refractive error, or rate of progression at baseline. It was also not linked to gender or family history of myopia. No adverse effects were reported during the trial.

References

1. ENTOD Pharmaceuticals receives DCGI approval for the world’s first 0.05% Atropine eye drops to slow down Myopia Progression in children. Press release. Entod Pharmaceuticals Ltd. Published April 22, 2025. Accessed April 23, 2025.
2. Rohit S, Gupta V, Thakur H, Dhiman R, et al. Indian J Ophthal. 2025;73(3): 358-361. doi:10.4103/IJO.IJO_1526_24