Low Dose Atropine (LDA) and the recent MHRA approval

There has been a major development in childhood myopia management in the UK. For the first time, low-dose atropine (LDA) – one of the most widely researched and evidence-backed treatments for slowing myopia progression – has received regulatory approval.

Santen has now been granted a CE mark and MHRA approval for Ryjunea, bringing licensed low-dose atropine eye drops a significant step closer to availability in the UK. This is something many eye care professionals and parents have been waiting for, and it could mark a real turning point in how we manage myopia in children.

For years, families have relied on unlicensed atropine “specials”, meaning access was inconsistent and often dependent on where they lived and which practitioners they could see. This new approval changes that. It provides a regulated, clinically tested option backed by long-term evidence – and crucially, it will make LDA far more widely accessible.

So what does this mean for parents?In simple terms: more choice, more consistency, and more confidence.Low-dose atropine has been shown to safely slow the progression of myopia in many children, reducing the long-term risks associated with high myopia such as glaucoma, retinal detachment and myopic maculopathy. Knowing that a fully licensed product is on the way allows families and practitioners to plan ahead with far greater clarity.

In the full article below, Jason Higginbotham breaks down what this approval means, who can prescribe it, possible side effects, how it compares with other therapies, and how it fits into the broader landscape of myopia management in the UK. Introduction

Myopia poses a long-term risk to the ocular health of a large and increasing proportion of the population¹.

Recently, there has been quite a lot of reporting about the licensing of Low Dose Atropine (LDA) in the UK for the purpose of myopia control².

The UK’s pharmaceutical regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), followed a recent approval by EMA (European Medicines Agency - the European equivalent of the MHRA), to approve Ryjunea®.

Produced by Sydnexis as SYD-101³, Santen holds the UK and EU license for the product. At present, Ryjunea is the only MHRA-licensed product for myopia control in the UK. It is, essentially, Atropine Sulphate.

Previously, un-licensed ‘specials’ were allowable on the RCOphth special orders list, including 0.01% Atropine.

Indication

The product has been licensed for use on patients aged between 3 and 14 years of age. They must be myopic, between -0.50 D to -6.00 D EQS and there must be documented progression of myopia of ≥0.50 D/year.

The drops are to be administered once daily per eye at bedtime.

Contraindication

Where a child has glaucoma, Ryjunea cannot be used. Also, if a child has a hypersensitivity to Atropine, the drug should not be used.

Care must be taken to avoid interactions with systemic medications.

Possible Side Effects

As the dose is very low, many potential systemic side effects are minimised in severity and likelihood of occurring (such as shortness of breath, dizziness, chest pains, etc).

However, the potential ocular side effects include⁴:

• Photophobia (light sensitivity)

• Blurred vision

• Eye irritation (redness and soreness)

• Occasional headaches (usually frontal)

Caution should be advised if a child is riding a bicycle, for example.

Also, the College of Optometrists suggests 3-6 monthly follow-ups checks with the prescribing clinician to check on the patient’s refraction, axial length, and any side effects⁵.

One of the primary effects of LDA is the dilation or widening (mydriasis) of the pupil. This is what causes the blurring and light sensitivity.

This image shows the difference between an eye without LDA drops and one with (*).

The standard drop bottle does contain BAK (Benzalkonium Chloride) which is a preservative. Some people do have a hypersensitivity to this chemical.

Other ingredients include:

• Boric acid

• Sodium Borate

• Sodium Chloride

• Sodium Edetate (EDTA)

• Purified water

Rarely, but occasionally, a few patients may be allergic to one or more of these compounds, though they are in very small concentrations.

Availability

Santen suggests the product will be available in the UK by Q2 2026. The company needs to ensure that pricing has been set correctly, distribution channels are in place and that there is a strong professional education programme in place before they release the product.

This is an impressive commitment to ensuring practitioners begin using it correctly.

Who can prescribe Ryjunea?

The College of Optometrists states that Ryjunea can be prescribed by “independent prescribers (IP) with relevant scope of practice, including IP optometrists and ophthalmologists with appropriate competence in paediatric myopia management.”

Ryjunea is a POM (prescription only medicine), hence why only IP optometrists can currently prescribe it. However, there may, in the future, be the possibility for non-IP optometrists using a signed order to supply LDA.

It is not yet decided if the NHS will prescribe LDA, including Ryjunea. This will depend on NICE’s appraisal of the product.

What will it cost?

The drug is already available in Germany. The annual cost of the drug in Germany appears to be approximately £550⁶, before any other professional fees and other expenses.

Ultimately, the end user price will depend on wholesale pricing (including the effects of any tariffs), the potential involvement of the NHS and the overall uptake of the drug (economies of scale).

Ryjunea seems a lot more expensive than simple Atropine 1%. However, it is important to note that a Ryjunea is supported by a large, long-term randomised controlled trial (STAR) and has had to go through many regulatory submissions (which are hugely expensive) and there are other costs, such as pharmacovigilance and supporting education, for example.

Other Therapies that might be used with Ryjunea?

There have been numerous studies over recent years suggesting that combination therapies for myopia control may provide better overall outcomes in slowing the progression of axial length (and the myopic refraction).

There have been multiple randomised controlled trials and meta-analyses of using LDA with Ortho-keratology (Ortho-K)⁷. It appears this combination has greatest effect in younger and faster progressing children.

Studies have also shown that children, with the supervision of their parents, make excellent contact lens wearers and, of course, these ‘night-lenses’ are much more convenient for children during the day as they are not worn.

That too can be said of Ryjunea drops. They would be instilled at night, perhaps at the same time the Ortho-K lenses are inserted.

Atropine and Defocus spectacles like Miyosmart and Stellest have also been shown to improve the efficacy of treatments for myopia progression⁸.

The same applies to LDA and soft multifocal contact lenses⁹.

Safety

• According to the STAR trial¹¹, for Ryjunea, the most reported side effect was photophobia (light sensitivity) – this occurred in 23.4% of users.

• 7.8% of users experienced blurred vision and 9.9% experienced eye irritation.

• However, only 0.4% of patients stopped using the drops due to adverse reactions over the total two-year trial period.

• Numerous studies have shown that LDA is well tolerated by children.

• It is a safe and effective treatment option for myopia control.

• Other options, especially contact lenses, do carry a slightly higher risk, due to the small, but real possibility of eye infections, like microbial keratitis.

• Spectacles don’t generally increase any risk of injury, but they can be inconvenient and some children have less self-confidence whilst wearing glasses.

Summary

There is considerable excitement in the UK optometry community around the introduction of Ryjunea / LDA for myopia control.

It offers a safe and effective therapy for reducing the speed of progression of axial length (the thing that causes the damage in myopia long-term).

The therapy is likely to be roughly similar in cost to many existing therapies, but, in combination, this could prove very expensive for many families.

Myopia Focus has a petition in place which aims to change the way myopia control is funded in the UK. Please visit our petition and sign it, so we can eventually lobby parliament to propose a fairer system of NHS eye care provision.

References:

1. Maulvi FA, Desai DT, Kalaiselvan P, Shah DO, Willcox MDP. “Current and emerging strategies for myopia control: a narrative review of optical, pharmacological, behavioural, and adjunctive therapies.” Eye, 2025; 39: 2635–2644.

2. RYJUNEA^® SmPC, April 2025.

3. Janet K Cheetham, et al. A Novel Low-dose Atropine eye drop slows the Progression of Paediatric Myopia:  Evidence from the STAR study. Sydnexis.

4. Summary of Product Characteristics: Ryjunea 0.1mg/ml eye drops, solution. European Medicines Agency.

5. MHRA approves first licensed low-dose atropine treatment for childhood myopia in the UK – College of Optometrists 10^th November 2025 online

6. Mediprice: RYJUNEA 0.1 mg/ml eye drops solution, 1 x 25 millilitres. https://www.medipreis.de/preisvergleich/ryjunea-0-1-mg-ml-augentropfen-loesung-1x2-5-ml-santen-gmbh-19731137

7. Yu S, Du L, Ji N, Li B, Pang X, Li X, Ma N, Huang C, Fu A. Combination of orthokeratology lens with 0.01% atropine in slowing axial elongation in children with myopia: a randomized double-blinded clinical trial. BMC Ophthalmol. 2022 Nov 15;22(1):438.

8. Guemes- Villahoz N, Talavero González P, PorrasÁngel P, et al. Atropine and Spectacle lens Combination Treatment (ASPECT): 12- month results of a randomised controlled trial for myopia control using a combination of Defocus Incorporated Multiple Segments (DIMS) lenses and 0.025% atropine. Br J Ophthalmol Epub ahead of print: doi:10.1136/ bjo-2024-326852

9. Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442.