10 June 2025
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.
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Nicholas Rumney01 July 2025
Fantastic news. Should be available in the UK soon though how the NHS embraces this will be interesting. Even if an optometrist is IP qualified and has access to FP10 prescribing this is almost always for acute conditions not chronic and of course ,myopia is not seen as chronic disease, yet.
GP's are reluctant to provide ongoing appropriate drops therapy when advised by IP optometrists who do not have access to FP10 and some baulk at supplying PF hypotensive.
It will be down to private sector primary care optometry who always lead the way in service development. We see this as a useful adjunct therapy for those on myopia control programmes. Unless or until NICE can approve NHS funding it will need private prescription, to be dispensed by pharmacy and monitored closely by IP optometrists. There is clearly minimal or no role for secondary care ophthalmology.
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