Japanese ophthalmology company Santen Pharmaceutical (TYO: 4536) announced that it will launch Ryjusea Mini solution 0.025% (tropine sulfate hydrate) on April 21, 2025.
The product is scheduled to be sold as a drug not listed in the National Health Insurance Drug Price Standard and will not be covered by public medical insurance. Ryjusea was approved by the Japanese regulator last December. The product was jointly developed by Santen and the Singapore Eye Research Institute (SERI), a national ophthalmic and vision research institute in Singapore.
Ryjusea is an ophthalmic solution containing 0.025% atropine sulfate hydrate. In a phase II/III placebo-controlled, double-masked comparative study conducted in Japan on myopia patients aged 5 to 15 years, the results verified that the product was superior to the vehicle in terms of the change from baseline in the cycloplegic objective spherical equivalent at 24 months after administration. Based on these results, Santen applied for manufacturing and marketing approval in February 2024. In December 2024, the product became the first in Japan to be approved for the indication of slowing myopia progression.
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