October 12, 2023
NEW ORLEANS, La. — At the 2023 American Academy of Optometry meeting held here, Visioneering Technologies Inc. shared interim one-year data from its PROTECT Trial (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial). The randomized controlled trial was designed to demonstrate the safety and effectiveness of NaturalVue Multifocal Contact Lenses for myopia progression control in children.
This multi-center, randomized, double-masked clinical trial has participating investigators in Canada, the United States, 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 final results of the study and any regulatory uses thereof will be based on the analysis of the complete three-year data set.
The presentation entitled, “Seeing is Believing: NaturalVue Multifocal 1-Year RCT Myopia Data Preview and Independent Real-World Retrospective Studies Data Comparison,” was delivered by Dr. Ashley Tuan, Chief Medical Officer for VTI, who shared the first analysis of the RCT study results and recapped the NaturalVue Multifocal 1 Day real-world data.
Dr. Tuan reported preliminary one-year results that demonstrate the safety and efficacy of NaturalVue Multifocal 1 Day Contact Lenses in slowing myopia progression, providing an important data point for eye care practitioners. Based on a preliminary analysis of the one-year follow-up from 93% of the enrolled subjects in the PROTECT Clinical Trial,* the treatment effect with NaturalVue Multifocal 1 Day Contact Lenses was 0.41D, or 69% for refractive error, versus the control group. For axial length, the treatment effect was 0.17 mm, or 59%, versus the control group. Combined with the six-year data previously published in Clinical Ophthalmology in 2022 and the analyses from other independent studies released in September 2023, this preliminary one-year data confirms that NaturalVue Multifocal effectively manages eye growth and refractive error change among progressing myopic children. To date, only six study subjects have voluntarily discontinued their participation, reflecting a low drop-out rate of 4%. VTI and the contract research organization conducting the study will continue to review and analyze the interim one-year data set and plan to share additional details in January 2024.
“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 pediatric patients,” said Dr. Ashley Tuan. “NaturalVue Multifocal 1 Day also provides clear vision for myopia correction and effectively slows myopia. 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.”
“Pediatric 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,” said Dr. Juan Carlos Aragón, Chief Executive Officer and Executive Director of VTI. “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.
“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,” Dr. Aragón continued. “The new interim results are outstanding and may support imminent partnering opportunities and commercial growth in key markets throughout Asia and Europe.”
VTI expects to release longer-term two- and three-year data when available.
To download a Fact Sheet summarizing the findings to date, click here.
To watch an interview with VTI’s CEO Dr. Juan Carlos Aragón, click here.
*Modified PP (Per Protocol) analysis including children between ages 8 and <13 with refractive error between -0.75 and -4.00 D versus age-matched controls wearing spherical lenses. SD = standard deviation.
Disclaimer: This information may describe uses for this product, i.e., Myopia Progression Control, which have not been approved by the FDA for use in the United States. It is intended for educational purposes only. NaturalVue Multifocal is part of an ongoing randomized clinical trial (RCT) studying its effectiveness for myopia progression control. This information has been reviewed and approved by VTI’s Promotional Review Committee.
In the United States, NaturalVue is FDA-indicated for myopia correction in children with no age or Rx restriction and may be used for myopia management. NaturalVue is also indicated for presbyopia management.
Outside of the U.S. — Canada, Europe, United Kingdom, Hong Kong, Singapore, Malaysia, Australia and New Zealand: NaturalVue is indicated for myopia progression control and for presbyopia management.