10 November 2025

MHRA approves first licensed low-dose atropine treatment for childhood myopia in the UK

Myopia

The Medicine & Healthcare products Regulatory Agency (MHRA) has approved the first licensed low-dose atropine (LDA) treatment for slowing the progression of childhood myopia.

Ryjunea® (low-dose atropine 0.1 mg/ml), licensed by Santen, is indicated for children aged 3–14 years with myopia between –0.50 DS and –6.00 DS and a progression rate of 0.50 DS or more per year. The product will be a prescription-only medicine (POM), available initially for private prescribing. NICE is awaiting ministerial approval to begin a technology appraisal of low-dose atropine, and it remains a privately funded intervention across the UK until the relevant national authorities (e.g. NICE for England, Northern Ireland, and Wales; Scottish Medicines Consortium for Scotland) completes their review.

"We welcome approval by the MHRA for a licensed LDA product for myopia management. This is a key milestone for the profession as it enables a therapeutic option for consideration when discussing treatment and monitoring plans with patients and their families. As with any new intervention or procedure, practitioners must work within their scope of practice whilst considering the patient’s best interests to ensure this treatment is provided safely and effectively."

Dr Paramdeep Bilkhu MCOptom, Clinical Adviser and IP Lead

Frequently asked questions

  1. Who can prescribe it? 
    Ryjunea® is a prescription-only medicine (POM). It may be prescribed by independent prescribers (IP) with relevant scope of practice, including IP optometrists and ophthalmologists with appropriate competence in paediatric myopia management.
  2. Will it be available on the NHS? 
    Initially, Ryjunea® will be available for private prescribing only. NICE is awaiting ministerial approval to undertake a technology appraisal. If found to be cost-effective by NICE, the NHS systems within England, Northern Ireland and Wales will be required to fund it. The Scottish Medicines Consortium will need to appraise the clinical and cost-effectiveness of this product before Health Boards can make it available on NHS prescription in Scotland.
  3. Can it be used in combination with myopia management contact lenses or spectacles? 
    Clinical decisions should be individual and based on clinical need. Current evidence suggests that combined therapy may offer additional benefit, but this is based on a limited number of trials with a low level of certainty regarding treatment effects. Clinicians should monitor efficacy, tolerance, and ensure parents understand the evidence base and desired treatment outcomes. In any case, standard refractive correction will be required alongside low-dose atropine treatment.
  4. How soon will it be available in pharmacies?
    Santen expects UK availability in early 2026, following completion of distribution, pricing, and professional-education arrangements.
  5. What will the private cost be? 
    Pricing is yet to be confirmed and will be dependent on pharmacy dispensing and local supply chains.
  6. What follow-up schedule should I use for children prescribed low-dose atropine? 
    Follow-up every 3–6 months is recommended to monitor refractive progression, axial length changes and side effects such as light sensitivity or near blur, as part of a dedicated myopia management follow-up appointment. However, you should use your professional judgement to determine the most appropriate schedule on a case-by-case basis.
  7. Are there any contraindications or safety considerations? 
    Low-dose atropine (0.1 mg/ml) is generally well tolerated, but adverse effects include photophobia (may be more than 1 in 10 people), glare, near vision blur and hypersensitivity reactions (may be up to 1 in 10 people).  Contraindications include history of known hypersensitivity reaction to atropine including any excipients (and other anti-cholinergic medications) and those with glaucoma (both open and closed angle subtypes). Full details and special precautions for use can be found in the summary of product characteristics.
  8. Where can I find professional guidance or training?
    It is important to ensure that you keep up to date with the evidence on myopia management, including risks, benefits, expected treatment outcomes and research limitations. Updates will be available through the College of Optometrists, Santen professional education, and forthcoming NICE guidance once the technology appraisal is complete.
    Assessing and managing children with myopia - College of Optometrists 
    Expanding scope of practice principles for optometrists - College of Optometrists 
    Expanding Prescribing Scope of Practice
  9. Will all optometrists be able to supply it?
    The Department of Health is currently holding a public consultation into expanding the list of exempted medications that all optometrists in the UK can supply. This includes the addition of atropine, and pending the result of the consultation, should legislation be changed, we are hopeful that non-prescribing optometrists with appropriate competence will be able to supply it via signed order.
  10. How effective is it compared to optical myopia management interventions?
    Most clinical trials on low-dose atropine compare efficacy to an inactive comparator (control).  Effects at one- and two-years provided evidence that these interventions may slow refractive change and reduce axial elongation, but the certainty of the evidence is low. Most head-to-head intervention studies involved comparisons between different doses of atropine or between atropine and orthokeratology (or in combination). The latter studies show similar levels of efficacy with respect to axial length progression and level of myopia at one- and two-years treatment. There are currently no studies of sufficient quality to compare atropine against other optical interventions.
    This means that although there is some research to show that low dose atropine compared to no treatment is effective, currently the evidence is not strong. This needs to be explained carefully to patients and their parents/carers so that they are able to make an informed decision about whether this is an intervention they wish to pursue.  
    Interventions for myopia control in children: a living systematic review and network meta‐analysis - Lawrenson, JG - 2025 | Cochrane Library
  11. I currently offer myopia management in my practice. Once low dose atropine products become available, do I need to discuss this as a potential treatment option?
    When providing myopia management services, you should keep up to date with the evidence, including new treatments. This means as part of the informed consent process, you should discuss all the available treatments (including low dose atropine and the option of no treatment) where - in your professional judgement - myopia management is clinically indicated an in the patient’s best interest. If you do not currently provide myopia management, you should still be able to discuss this and refer as appropriate.
    Assessing and managing children with myopia - College of Optometrists
  12. I currently offer myopia management in my practice, but I am not IP qualified. How can I provide low dose atropine treatment?
    You must only work within your scope of practice. That is where you have the relevant skills, knowledge and experience to provide treatments safely and effectively. So, if in your professional judgement you determine that low dose atropine treatment is appropriate, you should refer them to an IP qualified optometrist or ophthalmologist who provides myopia management services. Ideally, this process should be agreed in advance to ensure a suitable transfer for this aspect of eye care. Alternatively, you may consider developing an agreed co-management plan with an appropriate prescriber which set out clear lines of responsibility for treatment prescribing, monitoring (including effectiveness, side effects and adverse events) and management with suitable clinical governance structures in place to ensure patient safety. 
    Guidance for therapeutics - College of Optometrists
    Expanding scope of practice principles for optometrists - College of Optometrists

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