New Findings from 1-Year Analysis of VTI’s PROTECT Clinical Trial for Myopia Progression Control Presented at International Myopia Conference and Vision By Design

New observations suggest children, regardless of their pupil sizes, benefit from myopia treatment with NaturalVue® Multifocal lenses.

Highlights:

  • New findings:  Pupil Size
    • Children in the study experienced positive treatment effects with NaturalVue® Multifocal, regardless of their pupil sizes.
      • Larger pupil sizes corresponded with a greater treatment effect.
      • When the pupil is smaller (such as when patients spend time outdoors playing sports, etc.), the study suggests that nearly all patients should receive continuous, uninterrupted treatment with NaturalVue Multifocal.
  • New data analysis: Adjusted data (compared to previously released unadjusted analysis) statistically equalized other variables (age, sex, site and pupil size) that could also impact myopia progression and axial elongation.
    • Children wearing NaturalVue® Multifocal in the PROTECT Study showed significant improvement regardless of the type of analysis method:
      • 89% (0.48 D) reduction in refractive error progression vs. control (compared to 71% (0.41 D) in unadjusted data)
      • 58% (0.17 mm) reduction in axial elongation vs. control (similar to the 61% (0.17 mm) in unadjusted data)

The PROTECT study is ongoing, with further data expected to be analyzed and shared as it becomes available. The current findings reflect the study’s limitations in terms of age, race, geography, and study duration.

Hainan China; Dallas, Texas, October 4, 2024: Visioneering Technologies, Inc. (ASX: VTI) (‘Visioneering’ or ‘the Company’), manufacturer of NaturalVue® (etafilcon A) Multifocal 1 Day Contact Lenses, continues to release encouraging data from its ongoing PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue® Multifocal Contact Lens Trial) study. This randomized, double-masked, controlled clinical trial is designed to evaluate the safety and effectiveness of NaturalVue® Multifocal for myopia control in children.

The latest data, presented by Dr. Ashley Tuan, Chief Medical Officer at VTI, at both the International Myopia Conference and Vision By Design, highlights findings from an adjusted data analysis, complementing the previously shared unadjusted data. The poster, co-authored with Dr. Sally Dillehay, was titled, “Optical Defocus to Influence the Progression of Myopia and Eye Growth Shows Dosage-Dependency in Children”, also explored the treatment effect based on pupil size.

After equalizing other variables that also impact myopia progression (age, sex, site and pupil size), the adjusted outcome value could better represent the true effect of the treatment. The analysis revealed outstanding outcomes for NaturalVue® Multifocal, with an adjusted 89% (0.48 D) reduction in refractive error progression vs. control, compared to 71% (0.41 D) in the unadjusted analysis. Axial elongation showed a reduction of 0.17 mm (58%) vs. control, consistent with the 61% (0.17 mm) from unadjusted data. The adjusted analysis controls for external factors that may affect myopic progression, offering a more precise understanding of the treatment’s impact.

Treatment Effect and Pupil Size:

Children in the study experienced positive treatment effects with NaturalVue® Multifocal, regardless of their pupil sizes. However, the larger the pupil size, the greater the observed treatment effect.  For refractive error, this reduction reflects ≤ 0.25 D myopic progression – that is considered clinically insignificant. Adjusted mean myopia magnitude was not different from baseline.  With axial length the change is representative of near emmetropes. The study highlighted that even in children with smaller pupil sizes (those who spend considerable time outdoors, NaturalVue® Multifocal provided continuous treatment, underscoring the importance of consistent wear for optimal results.

Previously Reported Key Findings from 1-Year Data:

  • 58% of patients had physiological axial length growth similar to age-matched emmetropic children.
  • Average daily wear time with NaturalVue® Multifocal was 11-12 hours, matching control group usage and exceeding the study protocol (10 hours/day, 6 days/week).
  • These prolonged wearing times, paired with low dropout rates (4%), suggest excellent vision and comfort, key contributors to treatment compliance.

Looking Ahead:

Early findings from the 1-year data align with predictions for longer-term outcomes, with 3-year data expected to reinforce these results. The ongoing PROTECT trial will continue to analyze and share data as it becomes available. Combined with previously published 6-year data and analyses from three independent studies, these findings support the continued study of NaturalVue Multifocal’s effectiveness in slowing myopia progression across diverse patient populations and clinical settings.

Dr. Ashley Tuan, Chief Medical Officer of VTI, remarked: “Regardless of pupil size, all children in the study experienced a meaningful treatment effect with NaturalVue® Multifocal. These results further affirm our belief in the power of NaturalVue® Multifocal to effectively manage myopia in children.”

Dr. Juan Carlos Aragón, CEO and Executive Director of VTI, added: “The comprehensive data set from the PROTECT study solidifies NaturalVue® as a key tool for eye care practitioners managing myopia. The robust results provide assurance to both practitioners and parents that NaturalVue® offers excellent vision correction while helping to manage myopia.”

VTI plans to release 2- year and 3-year data as it becomes available, offering further insights into the long-term efficacy of NaturalVue® Multifocal lenses for myopia control.

To download a Fact Sheet summarizing the findings to date, click here. 

About Visioneering Technologies

Visioneering Technologies Inc. (ASX:VTI) is an innovative eye care company committed to redefining vision. A pioneer in presbyopia and myopia management, VTI merges advanced engineering with a relentless drive to achieve superior results for patients and practitioners. VTI’s flagship product is the NaturalVue® (etafilcon A) Enhanced Multifocal 1 Day Contact Lens, an extended depth of focus lens that the Company believes is one of the most significant innovations in the eye care industry in more than 20 years. For more information, please visit www.vtivision.com or call +1 844-884-5367, ext. 104.

* Note: This reflects the 1-year data set.  The PROTECT study is ongoing and data will be reviewed, analyzed, and shared as available. Data presented here are limited by the range of age, race, geographical locations and study duration.

Data is based on a 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

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.