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VTI Shares Preliminary Two-Year Data from PROTECT Study

January 17, 2025

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LAS VEGAS — Visioneering Technologies Inc. (VTI) has shared the preliminary two-year findings from its ongoing PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) study. Dr. Ashley Tuan, VTI’s Chief Medical Officer, shared the preliminary data during her presentation, entitled “The Latest Findings from the PROTECT Myopia Management RCT,” at the Global Specialty Lens Symposium (GSLS). 

Year 2 Preliminary Data Highlights

  • Year 2 Findings so far: 
    • Preliminary data shows sustained myopia progression control from both refractive error (0.60D) and axial length (0.25 mm)* perspectives.*
    • Results align with the treatment effects of the only FDA-approved therapy for myopia progression control.*
  • Real-World Corroboration: Findings reinforce prior real-world data and six-year studies on NaturalVue Multifocal 1 Day contact lenses.
  • Safety and Comfort: The study reports a low dropout rate, which is attributed to the lenses’ comfort and vision performance.

The two-year data underscores the safety and efficacy of NaturalVue Multifocal 1 Day Contact Lenses in managing myopia progression in children. The results demonstrate a significant reduction in refractive error and axial length growth compared to the control group. The two-year adjusted treatment effect* in refractive error progression was 0.60D, representing a 53% reduction compared to the control group. The two-year adjusted treatment effect* in axial length elongation was 0.25 mm, indicating an 86% retardation relative to the control group. Both two-year adjusted treatment effect values are consistent with the two-year values achieved by the only FDA-approved therapy for myopia progression control in a separate study.

PROTECT Year 1 Data Summary

  • Vision and Comfort: 
    • Maintained 20/20 or better high-contrast visual acuity at all distances, comparable to spectacles, with no clinically significant low-contrast reduction.
    • Results from the validated Patient-Reported Outcome PREP2** showed that children reported the same high level of satisfaction as those wearing single-vision contact lenses, with no perceived trade-offs in vision or comfort.
    • Preserved stereoacuity.
  • Astigmatic compatibility. 
    • Indicated to correct up to 2.00D of astigmatism. 
    • Demonstrated efficacy to correct 100% astigmatism at 2.00D and 83% at 3.00 D1
  • Normalized accommodative accuracy. To date, children have achieved relief from accommodative stress and improved performance for near tasks and digital device usage.
  • Continuous Treatment Effect Across Pupil Sizes: Proven efficacy through year one across pupil sizes (2–7 mm), ideal for children active outdoors or on digital devices. Nearly 2/3 of children achieved near-emmetropic change.

Combined with previously published six-year retrospective data and independent studies, these findings affirm NaturalVue Multifocal’s effectiveness in controlling myopia progression.

“Year one findings from the three-year trial demonstrate clear vision, safety, and comfort, leading to high compliance and effective outcomes and we expect to see this continue as we analyze more of the year two data,” said Dr. Ashley Tuan, VTI’s Chief Medical Officer.

“Based on the results from all recent clinical studies, NaturalVue Multifocal may be the only myopia management lens that can reduce vision challenges in all types of children,” said Chief Executive Officer and Executive Director of VTI, Dr. Juan Carlos Aragón.

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

 

References

*Data is based on 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. Adjusted data was equalized for key variables such as age, sex, and pupil size. Results noted actual values (vs. percentage; in diopters for refractive error and millimeters for axial length) that better represent the treatment effect which is helpful when comparing across studies.

**Pediatric Refractive Error Profile 2

1 Carracedo, G. Evaluation of Visual Acuity with Multifocal Catenary Curve-Based Contact Lens Design in Different Degrees of Astigmatism. Poster presented at Global Specialty Lens Symposium; January 17, 2025; Las Vegas, NV, USA.                                                                   

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