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HomeminewsFirst TGA Approved Eye Drop for Myopia Control

First TGA Approved Eye Drop for Myopia Control

The Therapeutic Goods Administration (TGA) has listed a new medication to slow the progression of myopia in children and young teenagers. Eikance 0.01% eye drops (atropine sulfate monohydrate 0.01%) are available on prescription for children aged four to 14 years, as a treatment to slow the progression of myopia and may be initiated in children when myopia progresses by one or more diopters per year.1

Myopia, also known as short-sightedness or near-sightedness, is a common condition that causes blurred distance vision and is often detected in childhood.2 Short-sighted children can often see reasonably clearly at short distances but will not be able to see distant objects clearly,2 for example a classroom whiteboard.

The most common cause of correctable vision impairment in the developed world,3 it is estimated that approximately 200,000 Australian children aged 0-14 years are living with short-sightedness.4,5,6

There are two main risk factors for a child 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

Eikance 0.01% eye drops (atropine sulfate monohydrate 0.01%) are available on prescription for children aged four to 14 years, as a treatment to slow the progression of myopia

Emerging data indicates that lockdowns during the COVID-19 pandemic 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. 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,” said Assoc. Adjunct Prof. Luke Arundel, Chief Clinical Officer at Optometry Australia.

“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, (the sensory layer at the back of the eye),” said Prof Arundel.

Eikance 0.01% eye drops are distributed in Australia by Aspen Australia and available on prescription in sterile, preservative-free single dose containers, providing parents with a consistent pharmaceutical formulation.9,10

Aspen Asia Pacific CEO, Trevor Ziman, welcomed the approval saying, “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, four to 14 years, to slow the progression of myopia. We are committed to helping manage this common cause of visual impairment in Australian children.”

About Eikance 0.01% Eye Drops

The TGA registration of Eikance 0.01% eye drops (atropine sulfate monohydrate) was based on several trials including two key randomised, double-blind clinical trials in children with myopia aged four to 12 years and six to 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

All medicines can have side effects. Most side effects of Eikance 0.01% eye drops are minor and temporary. The most common side effects of Eikance 0.01% eye drops 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. Patients should check with an eye care specialist or pharmacist about what medicines, vitamins or supplements they are taking and if these affect Eikance 0.01% eye drops.10

▼  This medicine is new or being used differently. Please report side effects. See the full CMI for further details

Consumer Medicine Information is available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-CMI-02407- 1&d=20211211172310101

 

References

  1. Therapeutic Goods Administration (TGA). 2021. Summary for ARTG Entry: 331960 [online] Available at www.ebs.tga.gov.au [Accessed 10 December 2021]
  2. Australia and New Zealand Child Myopia Working Group, The Australia and New Zealand Child Myopia Report – A Focus on Future Management.
  3. 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.
  4. Australian Institute of Health and Welfare. Eye of Health and Welfare. Eye Health. How common is visual impairment? [Accessed February 2022]
  5. Australian Bureau of Statistics. Twenty years of population change. [Accessed February 2022]
  6. Australian Bureau of Statistics. National, state and territory population. [Accessed February 2022]
  7. Theophanous C, Modjtahedi B, Batech M, et al. Myopia prevalence and risk factors in children. Clinical Opthalmology 2018:12 1581-1587.
  8. 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
  9. Australian Approved EIKANCE 0.01% EYE DROPS (atropine sulfate monohydrate 0.01%). Product Information. Last Updated 25 Nov 2021.
  10. Consumer Medicine Information (CMI) summary EIKANCE 0.01% EYE DROPS (atropine sulfate monohydrate 0.01%).

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