Santen Corporate (EN)

Santen Obtains Marketing Approval in the Philippines for STN1012700 (Ryjusea 0.25mg/mL Ophthalmic Solution), an Ophthalmic Solution to Slow the Progression of Myopia — First Approval in Santen’s Asia Business Region

June 26, 2026 – Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter “Santen”), announced today that it has received marketing approval in the Philippines for STN1012700 (Ryjusea 0.25mg/mL Ophthalmic Solution), a treatment indicated to slow the progression of myopia.

This approval marks the first licensed low-dose atropine treatment for this indication in the Philippines, and the first marketing approval of STN1012700 in Santen’s Asia business region*1. In Japan, the product has been available since April 2025 under the brand name Ryjusea® Mini Ophthalmic Solution 0.025%.

The marketing authorization is based on the results from ORANGE, a Phase II/III placebo-controlled, double-masked clinical study conducted in Japan. The study demonstrated clinically meaningful control of myopia progression, supporting its use as a safe and effective treatment option for those with myopia.

STN1012700 is a preservative-free, unit-dose ophthalmic solution, designed to provide consistent dosing and support safe, long-term use in children.

Santen’s Chief Medical Officer, Peter Sallstig commented:
“Childhood myopia is increasing at an alarming rate globally, with particularly high prevalence across Asia.1-2 The approval of STN1012700 in the Philippines marks an important milestone in addressing this growing unmet need in the region. STN1012700 combines clinical evidence from the ORANGE Phase II/III study with a child-friendly preservative-free, unit-dose formulation, offering ophthalmologists a well-characterized, evidence-based treatment option to slow myopia progression. At Santen, we are committed to advancing eye health and to improving outcomes for children affected by myopia. We will continue our efforts to make this new treatment available to patients across Asia, starting with the Philippines.”

About ORANGE, a phase II/III placebo-controlled, double-masked comparative study conducted in Japan among patients with myopia, the efficacy of the product was investigated by its superiority to the placebo group in terms of the change from baseline in the cycloplegic objective spherical equivalent at 24 months after administration. In addition, the product group showed a significant difference compared to the placebo group in the change from baseline in ocular axial length at 24 months after administration. Based on the above, the product demonstrated an effect of slowing myopia progression. Also, the product’s effectiveness was shown to be sustained over a three-year period. The most common adverse drug reaction in the study was photophobia, which occurred in 9.0% (11/122 cases).

References

  1. Holden BA et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. 2016.
  2. Rudnicka AR et al. Global variations and time trends in the prevalence of childhood myopia, a systematic review and quantitative meta-analysis: implications for aetiology and early prevention. 2016.

 

*1 Santen’s Asia business region excluding Japan and China

About Santen
Santen is a global pharmaceutical company committed to advancing eye health and improving lives through better vision. Founded in 1890 in Osaka, Japan, Santen makes use of more than 135 years of experience in research and development, manufacturing, and marketing of pharmaceuticals and medical devices to help people around the globe maintain and improve their eye health. Santen focuses exclusively on eye health and its portfolio includes glaucoma, dry eye, infection, allergy, age-related macular degeneration, and myopia. Santen’s products and services are available in more than 60 countries and regions. Guided by its Core Principle “Tenki ni sanyo suru” – Exploring the secrets and mechanisms of nature in order to contribute to people’s health – Santen combines its expertise with deep patient focus to contribute to the realization of “Happiness with Vision.”
For more information, please visit https://www.santen.com/en.

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