Medtech company Eyerising International Pty Ltd has announced its myopia management device – based on repeated low-level red-light (RLRL) technology that can be used at home – has been approved by the Australian Therapeutic Goods Administration (TGA).
The approval adds to existing regulatory clearances for the Eyerising Myopia Management Device from the Conformité Européene (CE) in the European Union, Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Medsafe in New Zealand, the National Medical Products Administration (NMPA) in China, as well as in Turkey.
Eyerising is currently preparing for Food and Drug Administration (FDA) approval in the US and has submitted approvals for the Singapore, Malaysia and India markets.
The Eyerising Myopia Management Device is described as a world-first technology to safely and easily treat myopia – and can be readily used at home.
Eyerising International CEO Mr Paul Cooke said the device is a safe, affordable, and proven technology. It treats myopia using RLRL that has been clinically proven to control myopia progression.
“The TGA has recognised the safety and performance of the device – the first evidence-based red-light therapy with demonstrated ability to effectively and safely control the progression of childhood myopia with potential life-long benefits in avoiding later eye disease,” he said.
The company has finalised distribution licenses with sales already taking place in Japan, New Zealand and Turkey. It is targeting a minimum roll out in 10 countries by the end of December 2023.
According to Eyerising International, the Eyerising Myopia Management Device can sustainably improve the way the eye functions through improved blood flow to thicken the choroidal layer of the eye wall in turn reducing eye elongation and myopia progression.
A recent study of RLRL for myopia control in children achieved 87.7% efficacy with no significant side effects.
The Eyerising Myopia Management Device is based on the work of Professor Mingguang He, a world-renowned ophthalmologist and myopia expert.
Eyerising said it is already in widespread use overseas with significant growing global market potential as myopia increases across populations including students. At current rates of progression, it is anticipated that one in two people globally will be myopic by 2050, with nearly 10% at risk of high myopia.
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