SYDNEY, March 17, 2022 /PRNewswire/ -- Aspen announced the Therapeutic Goods Administration (TGA) listing of a new medication to slow the progression of short-sightedness (myopia) in children and young teenagers. EIKANCE® 0.01% eye drops (atropine sulfate monohydrate 0.01%) are available on prescription for children aged 4 to 14 years, as a treatment to slow the progression of myopia and may be initiated in children when myopia progresses by 1 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. Myopia is 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]

There is emerging data indicating 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 Arundel.

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, 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."

About EIKANCE 0.01% eye drops (atropine sulfate monohydrate)

The TGA registration of EIKANCE 0.01% eye drops 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]

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. 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]

About Aspen Pharmacare Australia

Aspen Australia is the largest non-generic supplier of medicines by volume*^ in Australia with almost 500 product lines marketed in Australia.> Aspen Australia manages pharmaceutical products in most therapeutic categories including Prescription Pharmaceutical brands, Speciality pharmaceutical products, and OTC healthcare products.

For more details on specific Aspen products, please visit www.aspenpharma.com.au/products^[1]

*excludes compounding; ^ IQVIA MAT December 2021

>Dandenong, Australia manufactured and supplied by partner organisations

PBS Information:

This product is not available on the PBS.

• 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^[2]  

Notes to editors

No compensation was provided to Assoc. Adjunct Professor Luke Arundel for his involvement in this media activity, and the opinions expressed are his own. Assoc. Adjunct Professor Luke Arundel has been briefed by Aspen Australia on the approved use of this product and the Medicines Australia Code of Conduct. Assoc. Adjunct Professor Luke Arundel has served on advisory boards sponsored by Aspen Australia for which compensation was received.

References

1. ^{^} www.aspenpharma.com.au/products (www.aspenpharma.com.au)
2. ^{^} https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-CMI-02407-1&d=20211211172310101 (www.ebs.tga.gov.au)
3. ^{^} https://www.ebs.tga.gov.au (www.ebs.tga.gov.au)
4. ^{^} https://bjo.bmj.com/content/100/7/882 (bjo.bmj.com)