Newly Expanded Evidence from Clinical Practice on NaturalVue® (etafilcon A) 1 Day Contact Lenses for Paediatric Myopia Highl...
January 28 2018 - 5:59PM
Business Wire
On average, children experienced a 97% decrease
in myopic progression
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
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CompanyVisioneering Technologies, Inc.Stephen
SnowdyCEOssnowdy@vtivision.comorInvestor and media relationsWE
BuchanKyahn Williamson, +61 (3) 9866
4722kwilliamson@buchanwe.com.au
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