December 1, 2023
The presentation at the 2023 meeting of the American Academy of Optometry, “Seeing Is Believing: NaturalVue Multifocal 1-Year RCT Myopia Data Preview and Independent Real-World Retrospective Studies Data Comparison,” provided the first public analysis of preliminary one-year data from Visioneering Technologies Inc.’s PROTECT Trial (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial).
The preliminary one-year data appears to validate VTI’s expectations of the safety and effectiveness of NaturalVue Multifocal 1 Day Contact Lenses for slowing the progression of myopia in pediatric patients.
PROTECT Study’s Key Findings for ECPs
The randomized controlled trial was designed to demonstrate the safety and efficacy of VTI’s NaturalVue Multifocal 1 Day Contact Lenses (NVMF) for myopia progression control in children, important data points for eye care professionals. The trial was conducted across multiple centers and was randomized and double-masked with participating investigators in Canada, the United States, Hong Kong, and Singapore.
For ECPs, the key findings that can be drawn from this interim one-year analysis of the data are:
- The preliminary one-year findings affirmed NVMF may be safe and effective for use in myopia management.
- The average contact lens visual acuity from the Control group (single vision contact lenses) and the Treatment group (NVMF) are the same at distance (20/20 vs 20/20) and near (20/20+1 vs 20/20+1) at baseline and 12 months.
- Over 12 months, the study showed a 69% (0.41 diopter) reduction in refractive error compared to the control group. (Note, this reflects a modified per protocol analysis, including children between ages 8 and less than 13 with refractive error between -0.75D and -4.00D versus age-matched controls wearing spherical lenses.)
- The average axial length reduction was 0.17 mm (a notable 59% reduction) vs. control group for year one. This data aligns with prior real-world analyses, further validating NVMF’s efficacy.
- There was no device-related Serious Adverse Event.
PROTECT’S Preliminary Background and Predictions
In terms of additional background, it’s important to consider that the PROTECT trial reviewed one-year patient follow-up clinical data that corroborated with the Real-World publications on the safety and efficacy of NaturalVue Multifocal 1 Day Contact Lenses as a treatment for myopia progression control.
Looking ahead, PROTECT is designed as a three-year study with interim analyses planned after the one-year (just completed) and two-year subject follow-ups. One-year data from studies of similar design to PROTECT have been predictive of the expected three-year results.1
This preliminary one-year data supports the safety and effectiveness of NVMF for pediatric patients. The NVMF lenses not only ensure clear vision, but they also manage myopia, according to the analysis of the PROTECT data.
As of early October, six study subjects had 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.
Addressing One of Optometry’s Most Pressing Concerns
Today, we have come to understand that myopia is not just a simple condition, but rather it is an important eye health issue to address. It should not be regarded as a benign refractive condition to be managed simply with optical correction. Myopia can increase the risk for vision loss over the course of patients’ lives.
As a result, pediatric myopia is one of the most pressing concerns in optometry today, reaching epidemic proportions.
As the patient gets older, they will have an increased risk for more debilitating conditions because of their retinal health. The World Council of Optometry has declared myopia management the standard of care. Right now, there are over two billion myopes in the world’s population, and by 2050 we expect to have five billion in the population.
Why Are VTI’s Results So Exciting?
Note that the final results of the study and any regulatory uses thereof will be based on the analysis of the complete three-year data set.
VTI is most excited by the fact that the interim one-year results of the NaturalVue Multifocal 1 Day contact lenses are observed to be consistent with those of the only treatment approved by the U.S. Food and Drug Administration (FDA) for myopia progression control.
These results are exciting for several reasons, not the least of which is that what has been missing until now from VTI’s research are the data and findings from the randomized controlled trial, considered the most rigorous testing or experimenting available in the world of scientific evidence. This is because you can quantify the treatment effect in a controlled environment, and you have built-in cultural groups that you can use to calculate the treatment effect of the product.
The design and execution of the PROTECT study reflects the highest scientific standards for myopia progression control in pediatric patients. Its interim one-year data corroborates the NaturalVue Multifocal 1 Day real-world data analyses.
NaturalVue Multifocal Enhanced Contact lenses, with the patented Neurofocus Optics lens design, provides excellent vision now and into the future, and helps to manage myopia long term. The lens provides eye care professionals another great option to fight myopia while providing excellent vision and comfortable lens wear to kids of all ages.
As VTI has indicated, this preliminary data release signals the beginning of a new chapter for the company, securing its place on the global map as a positive intervention option in myopia management. These new interim results may also support imminent partnering opportunities and commercial growth in important markets throughout Asia and Europe.
- Brennan NA, Toubouti YM, Cheng X, Bullimore MA. Efficacy in myopia control. Prog Retin Eye Res. 2021; 83: 100923. doi.org/10.1016/j.preteyeres.2020.100923.