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The European Medicines Agency (EMA) has issued a positive recommendation for marketing authorization of Ryjunea, an eye drop formulation designed to slow the progression of myopia (nearsightedness) in children. Developed by Santen Oy, Ryjunea offers a potential new treatment option for young patients facing progressive myopia.
Ryjunea was submitted under a hybrid application, allowing the developer to leverage existing data from the already-authorized reference product, Atropin-POS, which has been available in the European Union since 2005. While both products contain atropine sulfate, Ryjunea is formulated at a lower strength and specifically targeted for the treatment of myopia progression.
Atropine, an anticholinergic agent, works by blocking muscarinic receptors in the eye. Although the precise mechanism by which it slows myopia progression is still under investigation, researchers believe it may involve influencing scleral remodeling and strengthening, ultimately reducing eye elongation and vitreous chamber depth.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its recommendation on a phase 3 clinical trial involving children aged 3 to 14 years. The study demonstrated that Ryjunea significantly slowed the mean annual progression of myopia compared to a vehicle control.
The recommended treatment protocol is for children aged 3 to 14 years with an annual myopia progression rate of at least 0.5 diopter (D) and a severity ranging from -0.5 D to -6.0 D. The EMA has emphasized that Ryjunea should only be prescribed by ophthalmologists or qualified eye care specialists.
Ryjunea will be available as a 0.1 mg/mL eye drop solution. Common side effects reported during clinical trials include photophobia (light sensitivity), eye irritation, and blurred vision.
Upon final marketing authorization by the European Commission, detailed prescribing information, including comprehensive safety and efficacy data, will be published on the EMA website. This will provide clinicians with essential information for informed decision-making regarding patient treatment.
Disclaimer: This news article is based on information provided by the EMA and is intended for informational purposes only. It should not be construed as medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment. Individual results may vary, and the information presented here does not guarantee specific outcomes. The availability and use of Ryjunea are subject to final marketing authorization by the European Commission and local regulatory approvals.(https://www.medscape.com/viewarticle/ema-recommends-ryjunea-pediatric-myopia-2025a10007ja)
