June 28, 2023
BERLIN, Germany — Dopavision’s MyopiaX-1 clinical trial centers are now all active, screening and enrolling participants across Germany, Spain, the Netherlands, and the United Kingdom.
The trial is designed to evaluate the safety, tolerability, and signals of clinical effect of MyopiaX, an innovative therapeutic intervention developed by Dopavision’s scientists and digital technology experts for the management of pediatric myopia.
The MyopiaX-1 clinical trial is based on extensive preclinical and translational research that provided the background for the study’s regulatory submissions and approvals. MyopiaX-1 is a randomized, active-controlled clinical trial, enrolling children with progressive myopia between the ages of 6 and 12 years and a refractive error between –0.75D and –5.00D. The trial is conducted in accordance with GCP guidelines. Dopavision is developing MyopiaX as an active medical device.
“MyopiaX is designed as a non-invasive therapy to trigger an increase in the eye’s natural production of dopamine, a molecule known to be involved in regulating eye growth,” said Mark Wuttke, CEO of Dopavision. “It is a light-based therapeutic technology that non-pharmacologically modulates the eye’s innate dopamine pathway. We believe MyopiaX has the potential to be the first clinically validated digital myopia intervention to target this key biological mechanism in the growing eye.”
“The MyopiaX-1 trial will provide the first clinical insights into this unique therapeutic approach to manage the progression of juvenile myopia,” said Prof. Ian Flitcroft, Principal Investigator at the Centre for Eye Research Ireland. “Using blue light to modulate the dopamine pathway in myopic eyes offers the potential for a novel, additional therapeutic option for myopia control.”
The coordinating center of the MyopiaX-1 clinical protocol is led by Prof. Ian Flitcroft and Prof. James Loughman of the Centre for Eye Research Ireland at the Technological University of Dublin in Ireland. The study rationale and design were presented at the European Society of Ophthalmology’s (SOE) Congress on June 15 in Prague. First results from the study are expected to be available in early 2024.
