VTI Announces Positive Interim 1-Year Data from the PROTECT Clinical Trial for Myopia Progression Control at the American Academy of Optometry Annual Meeting
NaturalVue® Multifocal 1 Day Contact Lenses Confirmed Safe & Effective for Myopia Management
Highlights:
· PROTECT multi-center, randomized, double-masked, controlled trial (RCT) 1-year patient follow-up clinical data corroborates the safety and efficacy of NaturalVue® Multifocal 1 Day Contact Lenses as a treatment for myopia progression control.
· The PROTECT study’s design and execution reflect the highest scientific standards for myopia progression control in pediatric patients.
· The treatment effect* was 0.41D (Diopters), 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.
· The interim 1-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 U.S. Food and Drug Administration (FDA) for myopia progression control.
· This interim 1-year data corroborates the NaturalVue Multifocal 1 Day real-world data analyses.
New Orleans, Louisiana, 12 October 2023: Visioneering Technologies, Inc (ASX:VTI) (‘Visioneering,’ ‘VTI’ or ‘the Company’), producer of the NaturalVue® Multifocal 1 Day Contact Lenses, presented the 1-year interim retrospective data of its PROTECT randomized controlled (RCT) at the American Academy of Optometry’s annual meeting in New Orleans today. PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens 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 3-year study with interim analyses planned after the 1-year and 2-year subject follow-ups. One-year data from studies of similar design to PROTECT have been predictive of the 3-year results. The final results of the study and any regulatory uses thereof will be based on the analysis of the complete 3-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.