October 7, 2024
BERLIN, Germany — Dopavision presented its six-month clinical trial data from its MyopiaX-1 trial at the 2024 International Myopia Conference. This first public presentation, delivered by Prof. Ian Flitcroft, DPhil, FRCOphth, Coordinating Investigator of the MyopiaX-1 trial, shared data supporting MyopiaX’s safety and signals of clinical effect on myopia progression over six months.
The presentation, entitled “MyopiaX-1 6-month safety and effect outcomes on the reduction of myopia progression: A randomized, controlled, multicentre trial,” showcased data from the first and key phase of the trial, where children with myopia in Europe used either MyopiaX alone or the active control. Participants in the MyopiaX arm (n = 50) had an average change from baseline of 0.14 mm in axial length and -0.19D in spherical equivalent refraction.
Children randomized to the active control arm (n = 34), who received spectacle lenses with defocus incorporated multiple segments (DIMS) technology, progressed 0.08 mm and -0.16D over the same period. The MyopiaX-1 trial was not statistically powered for planned between-groups comparisons, such as a non-inferiority analysis.
MyopiaX administers selective ocular light stimulation, targeting the blind spot, to increase melanopsin-mediated dopamine release and slow the progression of myopia. The intervention is delivered via a smartphone application, together with gaming accessories, to offer an interactive and accessible myopia control solution for children.
“MyopiaX’s selective ocular light stimulation technology is a unique approach,” said presenter Prof. Flitcroft. “It holds promise as a potential new addition to our toolbox as we seek to tailor treatments to each child’s individual profile throughout their myopia progression. These initial data from the MyopiaX-1 trial help further our understanding of the role of light in myopia control.”
Mark Wuttke, CEO of Dopavision, added: “The myopia epidemic is a significant global public health challenge. We are excited about these clinical data and MyopiaX’s potential as a new tool to combat this growing issue. With MyopiaX’s excellent safety profile and the signals of clinical effect it shows on myopia progression over six months, we’re looking forward to continue to progress this program.”
Further insights from the complete MyopiaX-1 trial and learnings from this proof-of-concept will inform future clinical studies and the ongoing development of MyopiaX.
