EU Approves Santen's Ryjunea for Children's Myopia

The European Commission has granted marketing authorisation for Santen Pharmaceutical's atropine eye drop, Ryjunea, which is designed to slow the progression of paediatric myopia. This approval makes Ryjunea the first and only therapy sanctioned in the European Union for this particular use. The eye drop, formulated as a 0.1 mg/mL ophthalmic solution, is intended for once-daily use and is specifically indicated for children aged 3 to 14 years who are experiencing myopia progression of at least 0.5 diopters annually, with severity ranging from -0.5 to -6.0 diopters.

Santen acquired the rights to commercialize this atropine formulation, known as SYD-101, in regions including the EU, Middle East, and Africa through a licensing deal with Sydnexis in 2021. The approval is considered a significant advancement for ophthalmologists who now possess an evidence-based treatment option for managing myopia progression in children. Peter Sallstig, Santen's chief medical officer, expressed confidence that this development provides a concrete medication to help slow down the condition's progression.

The European Commission's decision follows a favorable assessment by a European drug advisory panel in April, which endorsed the approval based on substantial data from the Phase III STAR study. This pivotal study demonstrated that Ryjunea can reduce myopia progression by 30% annually over a two-year period compared to placebo in children aged 3 to 14 years. The study's findings were crucial in establishing Ryjunea's efficacy in slowing down the progression of myopia.

In parallel, Sydnexis continues to hold the rights to the drug in the United States. Sydnexis successfully completed its regulatory filing with the FDA in March, and a decision from the agency is anticipated later this year. Patrick Johnson, president of Sydnexis, expressed enthusiasm about ongoing interactions with the FDA, particularly as the company's Prescription Drug User Fee Act (PDUFA) date approaches in late October.

Furthermore, Santen has developed a 0.025% variant of the product, which was previously approved in Japan and launched under the brand name Ryjusea Mini in April. This variant is also aimed at slowing myopia progression, demonstrating the company's commitment to providing solutions for this common visual impairment in children.

Overall, the approval of Ryjunea in the European Union represents a significant step forward in the treatment of paediatric myopia. By providing a scientifically supported option, ophthalmologists can better manage the progression of this condition, potentially improving the quality of life for affected children. With ongoing developments in the United States and other regions, the global reach of Ryjunea continues to expand, offering hope to many patients and healthcare providers dealing with myopia.