BERLIN– 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
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.
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.
“The six-month outcomes represent a significant step in the clinical development of MyopiaX,” said Prof. Ian Flitcroft, PhD, FRCOphth, Coordinating Investigator of the MyopiaX-1 trial. “The results are an important addition to the existing evidence supporting the mechanism of action of MyopiaX light stimulation.”
Dr. Mark Wuttke, CEO of Dopavision added: “The six-month findings of the MyopiaX-1 trial mark a monumental achievement for Dopavision. With MyopiaX, our goal is to enrich myopia management for millions of children worldwide, providing a safe, non-invasive and engaging alternative that empowers young people to build a healthier, brighter future.”
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.
