EC approves Santen’s Ryjunea to slow progression of paediatric myopia

Therapy indicated for children aged 3 to 14 at treatment initiation

Santen has announced that the European Commission has granted market authorisation for Ryjunea, a low-dose atropine eye drop (0.1 mg/ml), to slow the progression of paediatric myopia.

This approval represents a milestone in childhood eye care and offers a new option for managing myopia in children.

Ryjunea is indicated for children aged 3 to 14 years at treatment initiation, with myopia progression of 0.5 d or more per year and severity between -0.5 d and -6.0 d.

The product is licensed from Sydnexis Inc. to Santen’s affiliate, Santen sa, for registration and commercialisation across Europe, the Middle East and Africa.

The approval follows a positive opinion from the committee for medicinal products for human use and is backed by the phase 3 star study.

The study showed that Ryjunea reduced the annual progression of myopia by 30% over two years compared to placebo, with a favourable safety and tolerability profile.

Myopia, or short-sightedness, often develops in early childhood. If left unmanaged, it increases the risk of severe eye conditions later in life. In Europe, approximately one in three children and adolescents are projected to be affected by 2050. Until now, there was no approved pharmacological treatment in the eu to slow progression.

Peter Sallstig, Chief Medical Officer at Santen, said: “With this approval, clinicians now have an evidence-based option to help slow the progression of myopia.”

Marianthi Psaha, Head of EMEA at Santen, said: “Bringing this treatment to EU countries marks a significant milestone for our efforts to address childhood myopia across the region.”