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Newly Expanded Evidence from Clinical Practice on NaturalVue® (etafilcon A) 1 Day Contact Lenses for Paediatric Myopia Highlighted at the Global Specialty Lens Symposium (GSLS)

2018年01月29日 AM07:59
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Visioneering Technologies, Inc (ASX: VTI), a US-based medical device company (‘Visioneering’ or ‘The Company’) engaged in the design, manufacture, sale and distribution of its proprietary NaturalVue® Multifocal 1 Day (NaturalVue MF) Contact Lenses has today announced data presented at the Global Specialty Lens Symposium (GSLS). The new data highlights the impact of NaturalVue Multifocal on paediatric myopia. Myopia (also known as nearsightedness) is a condition with a rapidly increasing prevalence that currently impacts over 2 billion people worldwide. The retrospective data analysis presented at GSLS covers nearly 100 children across 12 different practice locations, more than tripling the number of children for whom data had previously been published. The data analysis of 3 groups of children showed that an average of 91 percent of children experienced a decrease in their myopic progression. The average amount of decrease of progression rate was 97%, and the most frequent finding was a 100% decrease in myopic progression (on an annualized basis). On average, 72 percent of children showed a complete halting of progression of myopic refractive error changes.

Brett O’Connor, OD, who presented Myopia Management with a Unique Extended Depth of Focus Contact Lens: A Case Series Analysis, summarized data from 27 children ages 8-16 years from 3 U.S.-based practice locations. The analysis of this group of children showed 96 percent of children had a decrease in the amount of their refractive error change on an annualized basis, with an average decrease of 103%, indicating many children (39%) demonstrated regression of some portion of their prior myopic refractive error change.

In Myopia Progression Before and After Fitting with NaturalVue Multifocal Contact Lenses: A Case Series Analysis, Thomas Aller, OD, FBCLA discussed his practice results from a series of 32 young patients ages 7-22 before and after switching to NaturalVue Multifocal. In this group of children, there was a 93% percent reduction of myopic refractive error change on annualized basis with 41% of these children demonstrating a regression of some portion of their prior myopic refractive error change. Dr. Aller also presented data on a subset of 15 children who had been previously prescribed an intervention for myopia prior to using the NaturalVue Multifocal. In these children, the amount of myopic progression reduced from -0.49D per year to -0.07D with NaturalVue Multifocal, a 86% decrease in myopic progression as compared to the prior interventions.

In the presentation Case Series Analysis of Myopic Progression Control with a Unique Extended Depth of Focus Multifocal Contact Lens, Sally M. Dillehay, OD, EdD, FAAO discussed results from the recent paper published in the peer-reviewed journal, Eye & Contact Lens.1 The retrospective analysis looked at 32 patients from children at 10 U.S.-based practices. In this group of children, 98 percent showed an average 96% reduction in myopic refractive error on an annualized basis. Additionally, in 81 percent of children there was complete halting or regression of myopic refractive error changes.

The presenters also noted that a percentage of children continued to progress in myopia, 8.4% in these 3 groups. In contrast, an average of 28.8% of the children in the 3 groups demonstrated a reduction (regression) in the amount of their myopic refractive error. The results of all 3 groups were quite promising with 91% of the children demonstrating an average 97% decrease in their myopic refractive error progression. Also, the data at 6-months of wear were highly consistent with 12, 18 and 24-month data, indicating that these changes in the progression of the myopic refractive errors are holding over the long term.

Dr. Dillehay, who serves as Chief Medical Officer and Vice President of Clinical, Medical and Regulatory Affairs for Visioneering Technologies, Inc., summarized the significance of the findings. “The consistency of these data across three different groups of children at diverse practice locations is exciting information in the quest to find better ways to manage myopia in clinical practice,” said Dillehay. “The fact that there was actually some regression in the amount of the myopic refractive error is especially promising and consistent with our prior findings in an animal (chick) model, where the lens design was shown to fully reverse approximately 10.00D of myopia in that animal model.2 We look forward to continuing to examine the impact of the NaturalVue Multifocal lens design on myopia and observed changes in refractive error and axial length.”

About VTI:

Visioneering Technologies, Inc. (VTI) is a US-based medical device company primarily engaged in the design, manufacture, sale and distribution of a revolutionary new contact lens: the NaturalVue® Multifocal (MF) contact lens. The NaturalVue MF contact lens employs VTI’s Neurofocus Optics™ technology, which was developed, refined and tested over many years. The characteristics of the NaturalVue MF contact lens allow it to be used in two of the largest eye-care markets globally: adults with presbyopia (age-related difficulty in seeing close objects) and children with myopia (near-sightedness, or difficulty seeing distant objects).

NaturalVue lenses were cleared by the FDA in late 2014 and VTI recently commenced its US market expansion for NaturalVue MF contact lenses, following a successful pilot US market launch in 2015 and 2016. VTI also sells and plans additional contact lens products.

Foreign ownership restrictions:

VTI’s CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. As a result of relying on the Regulation S exemption, the CDIs are ‘restricted securities’ under Rule 144 of the Securities Act. This means that you are unable to sell the CDIs into the US or to a US person for the foreseeable future except in very limited circumstances after the expiration of a restricted period, unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. To enforce the above transfer restrictions, all CDIs issued bear a ‘FOR US’ designation on the Australian Securities Exchange (ASX). This designation restricts any CDIs from being sold on ASX to US persons. However, you are still able to freely transfer your CDIs on ASX to any person other than a US person. In addition, hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.

1Cooper J, et al. Case series analysis of myopic progression control with a unique extended depth of focus multifocal contact lens. Eye & Contact Lens, October 2017: (e-published ahead of print) https://journals.lww.com/claojournal/Abstract/publishahead/Case_Series_Analysis_of_Myopic_Progression_Control.99309.aspx

2. Irving EL, Yacobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic & Physiological Opt 2017: 37(5):576-584.

MKT-VTI-PR51r0

View source version on businesswire.com: http://www.businesswire.com/news/home/20180128005069/en/

CONTACT

Company
Visioneering Technologies, Inc.
Stephen Snowdy
CEO
ssnowdy@vtivision.com
or
Investor
and media relations
WE Buchan
Kyahn Williamson, +61 (3) 9866
4722
kwilliamson@buchanwe.com.au

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