Remedy indicated for youngsters aged 3 to 14 at remedy initiation
Santen has introduced that the European Fee has granted market authorisation for Ryjunea, a low-dose atropine eye drop (0.1 mg/ml), to sluggish the development of paediatric myopia.
This approval represents a milestone in childhood eye care and provides a brand new possibility for managing myopia in youngsters.
Ryjunea is indicated for youngsters aged 3 to 14 years at remedy initiation, with myopia development of 0.5 d or extra per 12 months 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 throughout Europe, the Center East and Africa.
The approval follows a optimistic opinion from the committee for medicinal merchandise for human use and is backed by the section 3 star examine.
The examine confirmed that Ryjunea diminished the annual development of myopia by 30% over two years in comparison with placebo, with a beneficial security and tolerability profile.
Myopia, or short-sightedness, typically develops in early childhood. If left unmanaged, it will increase the chance of extreme eye circumstances later in life. In Europe, roughly one in three youngsters and adolescents are projected to be affected by 2050. Till now, there was no authorized pharmacological remedy within the eu to sluggish development.
Peter Sallstig, Chief Medical Officer at Santen, stated: “With this approval, clinicians now have an evidence-based possibility to assist sluggish the development of myopia.”
Marianthi Psaha, Head of EMEA at Santen, stated: “Bringing this remedy to EU international locations marks a major milestone for our efforts to handle childhood myopia throughout the area.”
Remedy indicated for youngsters aged 3 to 14 at remedy initiation
Santen has introduced that the European Fee has granted market authorisation for Ryjunea, a low-dose atropine eye drop (0.1 mg/ml), to sluggish the development of paediatric myopia.
This approval represents a milestone in childhood eye care and provides a brand new possibility for managing myopia in youngsters.
Ryjunea is indicated for youngsters aged 3 to 14 years at remedy initiation, with myopia development of 0.5 d or extra per 12 months 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 throughout Europe, the Center East and Africa.
The approval follows a optimistic opinion from the committee for medicinal merchandise for human use and is backed by the section 3 star examine.
The examine confirmed that Ryjunea diminished the annual development of myopia by 30% over two years in comparison with placebo, with a beneficial security and tolerability profile.
Myopia, or short-sightedness, typically develops in early childhood. If left unmanaged, it will increase the chance of extreme eye circumstances later in life. In Europe, roughly one in three youngsters and adolescents are projected to be affected by 2050. Till now, there was no authorized pharmacological remedy within the eu to sluggish development.
Peter Sallstig, Chief Medical Officer at Santen, stated: “With this approval, clinicians now have an evidence-based possibility to assist sluggish the development of myopia.”
Marianthi Psaha, Head of EMEA at Santen, stated: “Bringing this remedy to EU international locations marks a major milestone for our efforts to handle childhood myopia throughout the area.”
