Dopavision GmbH released new 6-month results from its proof-of-concept (POC) clinical trial evaluating the safety and tolerability of MyopiaX, its lead investigational candidate, aimed at delivering targeted photobiomodulation to pediatric patients.
Let’s start with Dopavision.
Founded in 2017 and based in Berlin, Germany, Dopavision is a private therapeutic company focused on developing therapeutic solutions for neurological and ophthalmic conditions via a proprietary photobiomodulation method that targets the eye’s blind spot.
Its first focus: pediatric myopia.
Now explain this investigational candidate.
MyopiaX is designed as a smartphone application with a non-invasive method that implements a targeted intervention to potentially both mitigate and manage myopia progression.
How it works: Once a virtual reality (VR) game session has been initiated (using the app), the technology keeps track of a child’s usage and performance in order to “optimize treatment” and “customize daily availability,” according to the company.
- What this involves: a VR headset and wireless controller
The goal: To increase dopamine levels in the retina to slow progressive myopia.
Back up: Why focus on dopamine?
Originally linked to eye growth control in 1989, hypotheses supporting “light-stimulated” dopamine as an therapeutic approach to manage and control myopia progression which has been the subject of multiple clinical studies over the last few decades.
Why: Dopamine can act as a chemical messenger and hormone (essentially, a neuromodulator) within the retina that manages biological functions such as the aforementioned eye growth, neurological development, visual signaling, and refractive development.
How it works: When the eye is exposed to natural light while outside, a trigger of increased dopamine is typically released into the retina.
- Such a surge in dopamine may help to regulate eye growth which could mitigate the risk for myopia development.
Gotcha. Now back to MyopiaX.
The child-friendly digital platform incorporates a light stimulus (developed by Dopavision) on top of the VR game that then activates a network of cells within the retina in order to increase dopamine production.
This light’s purpose: to “excite” a subset of photosensitive cells that provide input to dopaminergic amacrine cells (DACs).
- Note: DACs operate as the only source of retinal dopamine by carrying rod signals to retinal ganglion cells (RGCs).
The hypothesis: Such stimulation will then increase the release of retinal dopamine to, essentially, regulate eye growth and impact the rate of myopia progression, according to the company.
Can I get a visual of how this works?
Watch the video below.
Now talk about this clinical study.
The multicenter, randomized, controlled, single-masked trial (NCT04967287) called MyopiaX-1 has enrolled a total of 124 participants (aged 6 to 12) diagnosed with myopia (-0.75 to -5.0 D spherical equivalent of refraction [SER], least myopic meridian -0.50 D in each eye) across six European countries.
The duration: 12-month treatment period
How is it designed?
Participants are being randomized 2:1 to receive one of the following for the first 6 months of the study:
- MyopiaX (twice a day [BID])
- Myopia control spectacles (used as prescribed)
For the remaining 6 months, participants already receiving MyopiaX treatment will also receive the myopia control spectacles.
And the outcome measures?
Measured from baseline to 6 months, the primary outcome is change in axial length and in SER.
Other outcome measures will be measured at 12 months, including:
- Change in axial length and in SER
- Retinal and choroidal parameters
- Device usability (measured via user feedback questionnaire)
Total number of clinic visits: 5
And this topline data?
According to Dopavision, 6-month data has found that MyopiaX treatment among participants illustrates “signals of clinical effect on the rate of myopia progression.”Further: “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,” the company reported.
Nice! Is this the first clinical data on it?
Not quite. Dopavision noted that its previous POC research has already measured the following in humans to confirm that its light stimulus targets and activates the necessary cells within the retina:
- Pupil light response
- Retinal electrical activity
- Contrast sensitivity changes
Further: Preclinical non-human models also reportedly found “targeted light stimulation has the potential to inhibit the development of experimental myopia.”
Alrighty… so when can we expect the full 12-month data on this?
With the MyopiaX-1 trial scheduled to conclude in September 2024, likely shortly afterward.
Plus: The company also reported it’s in discussion with regulatory authorities regarding potential pathways for commercial development and approval of MyopiaX.
Stay tuned for more updates!