May 28, 2024
BERLIN, Germany — Dopavision has announced early findings from its clinical trial for MyopiaX-1. The six-month outcomes of the randomized, controlled trial (NCT04967287) 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 showed 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 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.
“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.”
“The six-month findings of the MyopiaX-1 trial mark a monumental achievement for Dopavision,” said Mark Wuttke, CEO of 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.
