Visioneering Technologies reports promising interim results from its PROTECT trial, showing significant control of myopia progression in children using NaturalVue® Multifocal lenses.
- 53% reduction in refractive error progression over two years
- 86% retardation in axial length growth compared to controls
- Data aligns with FDA-approved myopia control therapies
- Low dropout rate attributed to lens comfort and vision performance
- Results to be presented at the Global Specialty Lens Symposium
PROTECT Trial Advances Myopia Management
Visioneering Technologies (ASX: VTI) has released encouraging preliminary two-year data from its ongoing PROTECT clinical trial, which evaluates the efficacy of its NaturalVue® Multifocal 1 Day Contact Lenses in controlling myopia progression in children. The multicenter, randomized, double-masked study spans three years and involves 145 pediatric participants across the United States, Canada, Hong Kong, and Singapore.
The interim results reveal a 53% reduction in refractive error progression (0.60 diopters) and an 86% slowdown in axial length elongation (0.25 mm) compared to the control group wearing standard spherical lenses. These outcomes are particularly notable as they closely mirror the treatment effects observed with the only FDA-approved therapy for myopia control, underscoring NaturalVue Multifocal’s potential as a competitive alternative.
Safety, Comfort, and Real-World Validation
Beyond efficacy, the trial reports a low dropout rate, which Visioneering attributes to the lenses’ comfort and vision performance, key factors for pediatric compliance. This aligns with previous six-year retrospective real-world data and independent studies, reinforcing the lens’s consistent performance in diverse patient populations.
Dr. Ashley Tuan, Visioneering’s Chief Medical Officer, is set to present these findings at the Global Specialty Lens Symposium in Las Vegas, highlighting the company’s commitment to transparency and scientific rigor in advancing myopia management solutions.
Looking Ahead: Data and Market Implications
While these interim results are promising, Visioneering emphasizes that the PROTECT trial is ongoing, with more detailed two-year data and the full three-year results expected in due course. The company’s forward-looking statements cautiously note that NaturalVue Multifocal’s use for myopia control has not yet received FDA approval in the United States, signaling regulatory milestones still to be achieved.
Investors and industry watchers will be closely monitoring how these data influence market adoption and regulatory pathways, especially given the growing global concern over pediatric myopia and its long-term ocular health implications.
Bottom Line?
Visioneering’s latest data bolster NaturalVue Multifocal’s promise, but the path to FDA approval and market penetration remains a critical watchpoint.
Questions in the middle?
- Will the full three-year PROTECT data confirm sustained efficacy and safety?
- How soon might Visioneering pursue FDA approval for myopia control indications?
- What impact will these results have on competitive dynamics in the myopia management market?