Santen Receives UK Approval for Ryjunea® (low-dose atropine 0.1 mg/ml) to Slow Progression of Childhood Myopia

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Santen

05 Nov, 2025, 14:04 GMT

  • First MHRA-approved low-dose atropine eye drop to slow the progression of myopia (short-sightedness) in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D
  • Rates of childhood myopia in the UK have more than doubled over the past 50 years, driven by increased screen time and less outdoor activity[1,2]
  • Part of Santen's global effort to address the growing burden of childhood myopia through early, comprehensive care

LONDON and OSAKA, Japan, Nov. 5, 2025 /PRNewswire/ -- Santen today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ryjunea® (low-dose atropine 0.1 mg/ml), the first licensed treatment in the UK to slow the progression of myopia in children.[3] The approval follows the European Commission authorisation and the first launch in Germany earlier this year, with additional launches in Europe to follow.[4,5]

Short-sightedness is rising fast among children in the UK, where many children now live with myopia, more than double the number from 50 years ago.[1,2,6] Increased screen time, less outdoor activity, and intensive near work are putting a growing strain on young eyes.[2,7] Globally, approximately one in three children and adolescents are expected to be affected by 2050.[8]

The first signs of myopia often appear in daily life: a child squinting to read the board, moving closer to the TV, or struggling to recognise faces at a distance.[6] Myopia can affect learning, confidence, and participation in school and play.[9] Early interventions are key to slowing progression and supporting children's eye health and wellbeing.[10]

"We have a critical window in childhood to recognise myopia and act early," said Professor Annegret Dahlmann-Noor, expert in myopia management in London. Childhood myopia increases the risk of severe eye disease later in life. "A comprehensive approach, combining lifestyle habits, optical correction, and approved medical options, gives children the best chance to support healthy vision into adulthood."

"The UK approval is an important milestone in improving awareness and access to care for children with short-sightedness," said Neil Parkin, General Manager UK & Ireland, Santen. "We want to help shift the conversation from correction to control, supporting clinicians, schools, and parents to take early action."

With over 135 years of experience in eye health, Santen is committed to advancing early intervention and collaboration in paediatric myopia, for happier lives and brighter futures.

About Ryjunea ®
 Ryjunea ®  is a registered trademark of Santen Pharmaceutical Co., Ltd.  Ryjunea® is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D. It is backed by the Phase III STAR study, showing that Ryjunea® significantly reduced the annual progression of myopia with an acceptable safety and tolerability profile. As a low-dose atropine eye drop, administered once daily at bedtime, it provides a convenient way to manage myopia that integrates easily into a child's routine. The product is licensed from Sydnexis Inc. to Santen's Switzerland-based affiliate, Santen SA, for registration and commercialisation across Europe, the Middle East, and Africa (EMEA). It has received market authorisation from the European Commission on June 2, and now from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on October 30.

About Santen
As a specialised company dedicated to eye health, Santen aspires to contribute to the realization of "Happiness with Vision" by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its core principle, "Tenki ni sanyo suru," Santen has been committed to helping people maintain and improve their eye health for more than 135 years. Santen is engaged in global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen's mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience "Happiness with Vision."

For more information, please visit www.santen.com 

References

  1. UK Parliament. Screen time: impacts on education and wellbeing – Report Summary. 25 May 2024. Available online: https://publications.parliament.uk/pa/cm5804/cmselect/cmeduc/118/summary.html
  2. McCullough SJ, O'Donoghue L, Saunders KJ (2016) Six Year Refractive Change among White
    Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS ONE 11(1): e0146332. doi:10.1371/journal.pone.014633
  3. RYJUNEA®  MHRA, November 2025.
  4. RYJUNEA® SmPC, April 2025.
  5. Santen. (2025) European Commission Approves Santen's Ryjunea® to Slow Progression of Paediatric Myopia. [Press release]
  6. Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036-1042. doi:10.1016/j.ophtha.2016.01.006
  7. Specsavers. Screen time for kids: Impacts and advice from our experts. Available online: https://www.specsavers.co.uk/eye-health/screen-time-for-kids
  8. Liang J, Pu Y, Chen J, et al. Global prevalence, trend, and projection of myopia in children and adolescents from 1990 to 2050: a comprehensive systematic review and meta-analysis. Br J Ophthalmol. 2025;109(3):362-371. Published 2025 Feb 24. doi:10.1136/bjo-2024-325427
  9. Li D, Chan VF, Virgili G, et al. Impact of Vision Impairment and Ocular Morbidity and Their Treatment on Quality of Life in Children: A Systematic Review. Ophthalmology. 2024;131(2):188-207. doi:10.1016/j.ophtha.2023.09.005
  10. Lawrenson, J., Shah, R., Huntjens, B., Downie, L., Virgili, G., Dhakal, R., Verkicharla, P., Li, D., Mavi, S., Kernohan, A., Li, T., & Walline, J. (2021). Interventions for myopia control in children: a living systematic review and network meta–analysis. The Cochrane Database of Systematic Reviews, 2023. https://doi.org/10.1002/14651858.cd014758