The Therapeutic Goods Administration (TGA) has approved EIKANCE 0.01%, Australia’s first low-dose atropine eye drop for myopia progression in children and young teenagers.
The eye drop therapy – with the active ingredient atropine sulfate monohydrate 0.01% – is produced by Aspen Australia. It is now available on prescription for children aged 4 to 14 years, to slow myopia progression and may be initiated in children when myopia progresses by 1 or more diopters per year.1
The therapy joins an expanding suite of orthokeratology, soft contact lenses and defocus spectacle lens products with a myopia control indication in Australia. It will also provide eyecare professionals access to an atropine product under strict pharmaceutical control, with atropine typically accessed via compounding pharmacists.
Myopia is the most common cause of correctable vision impairment in the developed world3, and is estimated to affect approximately 200,000 Australian children aged 0-14 years. 4,5,6
According to an Aspen announcement, there are two main risk factors for children developing myopia: lifestyle and family history. Modern lifestyles such as low levels of outdoor activity, low levels of exposure to light such as sunlight,7 and reading and gaming on portable devices for long periods may influence the development of myopia.2
There is also emerging data indicating that lockdowns during COVID-19 may have led to an increase in the incidence of childhood myopia.8 The likelihood of developing myopia, particularly high myopia, increases when one or both parents have the condition.2 A survey showed that 91% of Australian parents were not aware of the role excessive screen time could play and 73% did not know that genetics might play a role.2
“The development of myopia is occurring younger in life, with the average onset about eight years old,” Associate Adjunct Professor Luke Arundel, chief clinical officer at Optometry Australia, said.
“It has been established that treating myopia in its early stages can slow its progression, which means that parents should seek medical advice from their optometrist as soon as they notice a deterioration in their child’s eyesight. As poor vision can impact a child’s development, we recommend that all children have a full eye examination before starting school, and regularly every two to three years as they progress through primary and secondary school.”
While myopia cannot be reversed, the goal of treatment is to keep it from progressing to high myopia where there are increased risks of permanent vision loss through glaucoma, cataract and problems with the retina, Arundel added.
EIKANCE 0.01% eye drops are available on prescription from community pharmacies in sterile, preservative-free single dose containers, providing parents with a consistent pharmaceutical formulation.9,10
Aspen Asia Pacific CEO, Mr Trevor Ziman, welcomed the approval: “Childhood myopia is an emerging public health concern. We are pleased to be able to provide a low dose atropine eye drop treatment to Australia that has been studied in children and adolescents, 4 to 14 years, to slow the progression of myopia. We are committed to helping manage this common cause of visual impairment in Australian children.”
Approval for low dose atropine
Aspen said the TGA registration of EIKANCE 0.01% was based on several trials including two key randomised, double-blind clinical trials in children with myopia aged 4-12 years and 6-12 years, who were treated with atropine 0.01% eye drops and followed for two to five years to assess the effectiveness and safety of atropine 0.01% eye drops in the treatment of childhood myopia.9
The company said all medicines can have side effects, with most side effects of EIKANCE 0.01% eye drops being minor and temporary. The most common are blurred vision, photophobia, allergy, sore, swollen, red and itchy eyes, headache and fatigue.10 For more information, see the full CMI.
Children should not use EIKANCE 0.01% eye drops if they are allergic to atropine, or any of the ingredients listed or have angle closure glaucoma or a family history of glaucoma.10
Some medicines may interfere with EIKANCE 0.01% eye drops and affect how it works. These include medicines to treat glaucoma, some medicines used to treat depression, some antihistamines, some medicines used to treat Parkinson’s disease, some medicines used to treat mental illness, medicines used to treat muscle weakness and potassium citrate and potassium supplements. Check with an eye care specialist or pharmacist about what medicines, vitamins or supplements you are taking and if these affect EIKANCE 0.01% eye drops.10
- Therapeutic Goods Administration (TGA). 2021. Summary for ARTG Entry: 331960 [online] Available at https://www.ebs.tga.gov.au [Accessed 10 December 2021]
- Australia and New Zealand Child Myopia Working Group, The Australia and New Zealand Child Myopia Report – A Focus on Future Management.
- Rudnicka A; Kapetanakis V; Wathern A; Logan N; Gilmartin B; Whincup P; Cook D; Owen C. Global variations and time trends in the prevalence of childhood myopia, a systematic review and quantitative meta analysis: implications for aetiology and early prevention. British Journal of Ophthalmology. Volume 100, Issue 7. Page 2 https://bjo.bmj.com/content/100/7/882.
- Australian Institute of Health and Welfare. Eye Health. How common is visual impairment? [Accessed February 2022]
- Australian Bureau of Statistics. Twenty years of population change. [Accessed February 2022]
- Australian Bureau of Statistics. National, state and territory population. [Accessed February 2022]
- Theophanous C, Modjtahedi B, Batech M, et al. Myopia prevalence and risk factors in children. Clinical Opthalmology 2018:12 1581-1587.
- Zhang X, Cheung SSL, Chan H, et al Myopia incidence and lifestyle changes among school children during the COVID-19 pandemic: a population-based prospective study British Journal of Ophthalmology Published Online First: 02 August 2021. doi: 10.1136/bjophthalmol-2021-319307
- Australian Approved EIKANCE 0.01% EYE DROPS (atropine sulfate monohydrate 0.01%).Product Information. Last Updated 25 Nov 2021.
- Consumer Medicine Information (CMI) summary EIKANCE 0.01% EYE DROPS (atropine sulfate monohydrate 0.01%).