1. Our vision
  2. Santen Receives Positive CHMP Opinion in Europe for Ryjunea® for slowing the progression of paediatric myopia

Santen Receives Positive CHMP Opinion in Europe for Ryjunea® for slowing the progression of paediatric myopia

Tue 15 April 2025

March 31, 2025 – Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for Ryjunea® (development code: STN1012701). Ryjunea® is a patented low-dose atropine ophthalmic formulation (0.1mg/mL), licensed from Sydnexis Inc. to Santen’s Switzerland-based affiliate, Santen SA, to commercialize in the regions of Europe, the Middle East, and Africa, for slowing the progression of paediatric myopia. The Marketing Authorization Application (MAA) for Ryjunea® was filed in March 2024 to the EMA.

The CHMP opinion was primarily supported by data from the STAR (STudy of Atropine for the Reduction of myopia progression in children) study. Ryjunea® met its primary endpoint demonstrating efficacy in slowing the progression of myopia in children at 24 months. The difference between Ryjunea®compared to placebo reached statistical significance in terms of annual progression of myopia in the patient population studied.

The primary endpoint was assessed by the mean annual progression rate of myopia at month 24 using the rate of change of the spherical equivalent, which is a simplified representation of an individual’s refractive error. The study results showed a favourable safety and tolerability profile of Ryjunea® in the patient population studied. The study was conducted in 852 randomised male and female paediatric participants with myopia between the ages of 3 to 14 years old at the time of study initiation.1 The STAR study was designed to continue for a total of 48 months and is estimated to be completed in the summer of 2025.

“Ryjunea® exemplifies Santen’s dedication to deliver innovative treatment options that meet the needs of patients with myopia in Europe, the Middle East, and Africa. This positive opinion from the CHMP represents a critical milestone in our efforts to make Ryjunea® available, supporting early intervention in patients with paediatric myopia, with treatments designed to slow its progression,” commented Peter Sallstig, Chief Medical Officer, Santen.

“Santen has been a great partner and is very passionate about this product,” said Patrick Johnson, President of Sydnexis. “We are excited for Santen to bring Ryjunea®’s novel and proprietary low-dose atropine formulation to millions of paediatric myopia patients across multiple continents.”

Myopia (or near-sightedness) is a refractive error causing objects in the distance to appear blurred while near objects appear clearly because the eyes cannot focus light correctly.2,3 It is irreversible and affects patient quality of life (QOL). 4,5 If progress continues, there is reportedly a higher risk of experiencing severe complications later on, which may result in blindness. 6,7 Early intervention in myopia significantly diminishes the likelihood of these severe, vision-threatening complications later in life.8 The global prevalence of myopia (or near-sightedness) was approximately 34% in 2020 and is projected to increase to almost 50% by 2050, affecting 5 billion people worldwide.9,10 In Europe alone, the prevalence is predicted to increase to almost 42% by 2030.11

References

  • A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101

  • Ophthalmic Solution for the Treatment of Myopia in Children. ClinicalTrials.gov ID (NCT03918915).

  • World Health Organization World Report on Vision 2019. ISBN 978-92-4-151657-0.

  • Németh et al, European Journal of Ophthalmology. 2021; 31(3):853-883.

  • Han X et al, Curr Eye Res. 2023;48(12):1189-1194.

  • Sankaridurg P et al, Invest Ophthalmol Vis Sci. 2021;62(5):2.

  • Morgan IG et al, Lancet. 2012;379(9827):1739-48.

  • Haarman A et al, Invest Ophthalmol Vis Sci. 2020;61(4):49.

  • Surico PL et al, Children 2024, 11(12), 1446.

  • Burton MJ et al, Lancet. 2021; 9(4): 489-551.

  • Eye Disease Prevalence Research Group. Arch Ophthalmol. 2004; 122(4): 495-505.

  • Holden BA et al, Ophthalmol. 2016;123(5):1036–42.


About Santen

As a specialized 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 130 years. Santen is engaged in the 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 Santen’s website https://www.santen.com/en.

Contact

Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com