By Fineline Cube 
Japan‑based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced that its RYJUSEA (atropine sulfate hydrate) has received marketing approval from the Boao Lecheng Pilot Zone for the treatment of myopia in children and adolescents.
Product Overview
- Active Ingredient – Atropine sulfate (0.05 % w/v)
- Formulation – Preservative‑free to minimise ocular irritation and ensure long‑term safety in pediatric patients
- Mechanism – Inhibits axial elongation of the eye, thereby slowing progression of myopia
Clinical Evidence
| Parameter | RYJUSEA | Placebo | P‑value |
|---|---|---|---|
| Spherical Equivalent Refraction (24 mo) | –1.006 D | –1.643 D | <0.0001 |
| Axial Elongation (24 mo) | 0.51 mm | 0.74 mm | <0.0001 |
| Spherical Equivalent Refraction (36 mo) | Sustained benefit | – | – |
| Axial Elongation (36 mo) | Sustained benefit | – | – |
Phase 2/3 studies demonstrated that RYJUSEA significantly outperformed placebo in controlling both spherical equivalent refraction and axial elongation. The therapeutic effect persisted throughout the 36‑month treatment period, with no unanticipated safety concerns identified.
Regulatory Milestone
The Boao Lecheng Pilot Zone approval positions RYJUSEA for commercial launch across mainland China, Hong Kong, Macau and Taiwan, providing a new, evidence‑based option for clinicians treating pediatric myopia.
Market Implications
- Growing Demand – Rising prevalence of myopia in East Asia and increasing parental awareness create a sizable market opportunity.
- Competitive Edge – Preservative‑free formulation and robust clinical data differentiate RYJUSEA from existing atropine products.
- Strategic Growth – The approval aligns with Santen’s broader expansion strategy in ophthalmic therapeutics.-Fineline Info & Tech