28th May, 2024
MyopiaX-1 proof-of-concept clinical trial supports MyopiaX’s safety and tolerability profile
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Dopavision, a pioneering company dedicated to transforming pediatric eye care, today announced topline findings from its MyopiaX-1 proof-of-concept clinical trial (NCT04967287). The six-month outcomes of the randomized, controlled trial demonstrate the safety and tolerability of MyopiaX. MyopiaX delivers targeted photobiomodulation to the eye with the aim of managing the progression of myopia among children.
MyopiaX is a first-in-class, targeted intervention that non-invasively stimulates specific cells in the eye to regulate innate signaling pathways and slow the rate of myopia progression. MyopiaX offers an intuitive and child-friendly digital platform that seamlessly integrates myopia treatment into daily routines leveraging consumer electronics. This approach facilitates ease of use and broad accessibility worldwide, aiming to address the growing global public health challenge of myopia, with projections indicating nearly half of the world’s population will be myopic by 2050.
The outcomes of the MyopiaX-1 trial add to the growing body of scientific evidence supporting MyopiaX’s mechanism of action and its potential therapeutic application to slow myopia progression.
Conducted across six European countries, the trial randomized 124 myopic children in a 2:1 fashion to MyopiaX or a control group. Over six months, treatment with MyopiaX shows signals of clinical effect on the rate of myopia progression. MyopiaX was safe and tolerable over the six-month trial period, with no ocular safety events reported, validating MyopiaX as a low-risk, non-invasive approach. The ongoing MyopiaX-1 clinical trial is scheduled to complete in September 2024. Dopavision is engaged in discussions with regulatory authorities to outline the potential pathways for MyopiaX’s development and approval.
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