The European Commission has granted market authorization for Ryjunea®, a low-dose atropine eye drop developed by Santen Pharmaceutical Co., Ltd., For the first time in Europe, children struggling with worsening vision have a clinically proven treatment to slow myopia.
Myopia, or short-sightedness, often begins in early childhood and can progress rapidly. If left unmanaged, it increases the lifetime risk of serious eye conditions such as retinal detachment, glaucoma, and macular degeneration.1,2 Beyond physical health, myopia can also affect a child’s participation in learning and day-to-day activities.3 Until now, treatment options have been limited to glasses or contact lenses that correct blurred vision but do not address progression.
Ryjunea (0.1 mg/ml) is indicated for children aged 3 to 14 years with progressing myopia of 0.5 diopters (D) or more per year and a refractive error between -0.5 D and -6.0 D. Unlike traditional glasses or contact lenses, which only correct vision, Ryjunea targets the progression of myopia itself.
The approval is based on the pivotal Phase III STAR study, which demonstrated that Ryjunea reduced the annual progression of myopia by 30% over two years compared to placebo [data on file]. The study also confirmed a favourable safety and tolerability profile, positioning the once-daily bedtime drop as a convenient and effective treatment.
References:
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Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123:1036-42.
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Morgan IG, Ohno-Matsui K, Saw M-S. Myopia. Lancet. 2012;379:1739-48.
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Chua SYL, Sabanayagam C, Cheung Y-B, et al. Ophthalmic Physiol Opt. 2016;36:388-94.
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