The European Commission has granted approval to Santen’s Ryjunea for the management of childhood myopia.
A statement from Santen highlighted that the 0.1mg/ml atropine eye drop has received approval for children between the ages of three and 14 at the initiation of treatment with myopia progression of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.
The approval follows results from the Phase III STAR study, which found that Ryjunea reduced annual progression of myopia by 30% over two years when compared to a control group. The study also reported that the eye drop had a favourable safety and tolerability profile.
Santen chief medical officer, Peter Sallstig, highlighted: “We believe that a clinically-proven and regulatory-approved, low-dose atropine will be an important component of a comprehensive strategy for myopia control in children.”
He observed that watching a child’s myopia worsen year after year can be “deeply worrying” for families.
“Ryjunea offers the opportunity to act early. As a low-dose atropine eye drop, administered once daily at bedtime, it provides a convenient way to manage myopia that integrates easily into a child’s routine,” Sallstig said.