– MyopiaX-1 trial to generate first clinical evidence with MyopiaX®, a novel therapeutic approach to manage myopia progression
– First data readout expected in Q1/ 2024 with study completion planned for September 2024
Berlin, Germany, September 26, 2023 — Dopavision, a clinical-stage company developing innovative solutions for the management of myopia, today announced the successful completion of enrollment in its MyopiaX-1 trial (NCT04967287). MyopiaX-1 is a randomized, active-controlled trial to evaluate the safety, tolerability, and clinical outcomes of MyopiaX® in pediatric participants with myopia. The first clinical results are expected in the beginning of 2024 and the 12-month MyopiaX-1 trial is scheduled to be completed in September 2024. The MyopiaX-1 trial is being conducted at 10 clinical sites in Germany, the Netherlands, Portugal, Spain, and the United Kingdom.
The MyopiaX-1 clinical trial is a proof-of-concept investigation generating the first clinical evidence with MyopiaX®. More than 100 children between the ages of 6 and 14 years with progressive myopia and a refractive error between –0.75 and –5.00 diopters were randomized to participate in the 12-month trial. The enrolled participants were randomized in a 2:1 ratio to receive either MyopiaX® or myopia control spectacles for the first 6 months. During the second half of the study, participants in the MyopiaX® group will add the myopia control spectacles. An independent Data Safety Monitoring Board reviews the clinical safety outcomes of the randomized trial participants on a quarterly basis. Dopavision is developing MyopiaX® as an active medical device.
“Pediatric myopia is a global public health problem that presents a significant burden for children, with an increased risk of long-term eye health complications and impaired quality of life,” said Mark Wuttke, CEO of Dopavision. “We designed our treatment approach to control myopia progression as a non-invasive, non-pharmaceutical method. Developed as a smartphone application, MyopiaX® is accompanied by fun virtual reality content, easy for children to use, and has the potential to broaden access for a larger number of people suffering from myopia. The MyopiaX® app administers an intervention that targets the eye’s innate growth mechanisms using blue light delivered to the optic nerve head. The MyopiaX-1 study is designed to provide the first clinical insight into the effects of MyopiaX®, and we are very pleased to have reached this important milestone with the completion of the trial enrollment.”
While the MyopiaX-1 trial is ongoing, Dopavision is committed to generating further scientific and clinical evidence to optimize MyopiaX® for all users and stakeholders.
MyopiaX-1 clinical trial sites
- Südblick GmbH, Augsburg, Germany
- MVZ Makula-Netzhaut-Zentrum Breyer Kaymak, Düsseldorf, Germany
- BeyondEye Clinic, Köln, Germany
- University Medical Center, Johannes Gutenberg University, Mainz, Germany
- University Eye Hospital Tübingen, Tübingen, Germany
- Erasmus University Medical Center, Rotterdam, Netherlands
- University of Minho, Braga, Portugal
- Hospital Sant Joan de Déu, Barcelona, Spain
- University Complutense of Madrid, Madrid, Spain
- Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom
MyopiaX-1 trial coordinating site
- Centre for Eye Research Dublin, Technological University Dublin, Dublin, Ireland
###
About Dopavision
Dopavision is set to develop disruptive treatments in ophthalmology and beyond by targeting the body’s known biological pathways, using light and digital technologies. Its first goal is to provide an innovative, clinically validated intervention to manage myopia non-invasively by leveraging the eye’s innate dopamine-related growth mechanisms. Dopavision is backed by top-tier international investors such as Seventure Partners, Novartis Pharma (dRx Capital), Boehringer Ingelheim Venture Fund, and Ababax.Health and is supported by the German government via the “Industrie-in-Klinik” program of the German Federal Ministry of Education and Research BMBF.
For further information please contact:
Dopavision GmbH
Mark Wuttke
Chief Executive Officer
info@dopavision.com
Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 /
Tel. +49 30 23 63 27 68
Our Partners
Dopavision is funded as part of the BMBF’s Industry-in-Clinic Platform Program (FKZ: 13GW0625)