German medical software company Dopavision has announced positive results from its MyopiaX-1 proof-of-concept clinical trial examining its smartphone app designed to advance the recovery of children who have had photobiomodulation treatment for myopia.
The company describes the app as a first-in-class, targeted intervention that non-invasively stimulates specific cells in the eye to regulate innate signalling pathways and slow the rate of myopia progression.
MyopiaX uses the user’s phone light functions with a headset and a child-friendly interface to progressively advance a child’s recovery.
Six-month outcomes from the MyopiaX-1 trial (NCT04967287) found that repeated use of the app over six months showed signals of clinical effect on the rate of myopia progression while also being safe and tolerable over those six months with no safety events reported. The trial examined the app among a randomised group of 124 children with myopia from across six European countries.
Dopavision CEO Mark Wuttke said: “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.”
According to the American Academy of Ophthalmology, it is caused as a result of the eye being slightly more elongated than usual, causing the cornea to be too steeply curved to properly take in light, with the condition affecting as many as 50% of the US population in some form as well as more prevalent among children. If untreated the condition can eventually lead to other eye conditions such as cataracts, glaucoma, and retinal detachment.
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Ian Flitcroft, coordinating investigator of the MyopiaX-1 trial, added: “The six-month outcomes represent a significant step in the clinical development of MyopiaX. The results are an important addition to the existing evidence supporting the mechanism of action of MyopiaX light stimulation.”
The current MyopiaX trial is still ongoing with the company saying it expects it to run until September 2024, meanwhile, the company adds that it is in talks with regulators in hopes of clearing the way for market approval of its child-friendly app.
Elsewhere in the field of myopia treatment, US giant Johnson & Johnson Vision is set to unveil its Elita laser correction device for minimally invasive surgical correction. At the same time, in the area of software as a medical device (SaMD), the UK’s British Standards Institute has established a specialised regulatory team aimed at regulating the fledgling sector.
