Visioneering Technologies Inc (VTI) has announced positive interim one-year data from the PROTECT clinical trial of its paediatric myopia progression control contact lenses, NaturalVue Multifocal 1 Day.
The results, announced at the American Academy of Optometry Annual Meeting in October 2023, confirm the safety and efficacy of its NaturalVue Multifocal 1 Day contact lenses in myopia progression control, the company announced.
According to VTI, which is listed on the ASX, the lenses have demonstrated the highest scientific standards for myopia management in children with a treatment effect of 69% for refractive error and 59% for axial length versus control group.
“Paediatric myopia is one of the most pressing concerns in optometry today, reaching epidemic proportions. VTI has been a pioneer in correcting myopia and protecting children with our innovative and easy-to-fit lens design,” VTI CEO and executive director Dr Juan Carlos Aragón, said.
“That’s why we’re excited to announce the one-year interim results of our PROTECT clinical trial that demonstrates the effectiveness of NaturalVue Multifocal 1 Day for myopia management in children.”
The interim one-year treatment effects of the NaturalVue Multifocal 1 Day contact lenses are observed to be consistent with those of the only treatment approved by the FDA for myopia progression control, VTI said, referring to CooperVision’s MiSight 1 day contact lens.
“It’s exciting to see that the preliminary one-year data validates our expectations of the safety and effectiveness of NaturalVue Multifocal contact lenses for paediatric patients. NaturalVue Multifocal 1 Day also provides clear vision for myopia correction and effectively slows myopia,” VTI CMO Dr Ashley Tuan said.
“The interim one-year treatment effects are consistent with those of the only treatment approved by the FDA for myopia progression control, which we view as a positive result. We look forward to sharing more data from the study in the future.”
The multi-centre, randomised, double-masked clinical trial has participating investigators in Canada, the US, Hong Kong, and Singapore. PROTECT is a three-year study with interim analyses planned after the one-year and two-year subject follow-ups. One-year data from studies of similar design to PROTECT have been predictive of the three-year results. The results of the study and any regulatory uses thereof will be based on the analysis of the complete three-year data set.
“This data release signals the beginning of a new chapter for VTI as we secure our place on the global map as a positive intervention option in myopia management. The new interim results are outstanding and may support imminent partnering opportunities and commercial growth in key markets throughout Asia and Europe,” Carlos Aragón said.
VTI expects to release longer-term two- and three-year data when available.
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