Thomas Aller, OD, FBCLA, an internationally recognized expert in
nearsightedness in children, has presented updated findings from a
prospective clinical trial of NaturalVue® (etafilcon A) 1 Day
Multifocal Contact Lenses from Visioneering Technologies, Inc. Dr.
Aller presented the data at the American Academy of Optometry (AAO)
Conference in San Antonio Texas on November 9.
Dr Aller, who is a practicing optometrist and Visiting Scholar
at the UC Berkeley School of Optometry, highlighted how VTI’s
unique contact lens design continues to show promise in managing
nearsightedness in children (paediatric myopia).
Between October 2017 and January 2018, multiple eye care
practices released peer-reviewed data showing nearly 60 children
for whom NaturalVue Multifocal had slowed the progression of
nearsightedness by 96% on an annual basis.1,2 It is generally
thought that minimizing the progression of nearsightedness is an
important intervention aimed at minimizing life-time risks of
blindness and other serious ocular diseases that are related to
nearsightedness.
Starting in 2017, Dr. Aller spearheaded a prospective,
registered clinical trial (NCT03358862) with the objective of
quantifying changes in vision (refractive error) and eye shape
(axial length) in myopic children wearing NaturalVue Multifocal
contact lenses. To date, 24 children have completed at least one
6-month follow up visit, and 19 children have worn the lenses for
more than one year. The average age of this sample population was
10.8 years old (range 7-17), with approximately half of the
children (50%) having some Asian ethnicity.
Prior to wearing NaturalVue Multifocal, the children were
worsening in their myopic vision by 1.28 ± 0.79 dioptres per year,
a rate of worsening that many practitioners consider to be quite
aggressive, given that the average amount of progression is
approximately 0.50 dioptres per year.3 In contrast, children
wearing NaturalVue Multifocal experienced a rate of worsening of
0.24 dioptres per year, a decreased change of 1.04 dioptres per
year (statistically significant, P<0.01), representing an 81%
decrease in the rate of myopia progression.
In addition, the children in Dr. Aller’s study who wore
NaturalVue Multifocal experienced slower changes to the shape of
their eyes, compared to the rate of change one would expect in
children with a similar level of aggressive worsening of myopia.
Using published estimates of axial length change based on the prior
year’s refractive error change (1 mm=3.00 D),4 these children would
have been predicted to have shown an increase in axial length of
0.43 ± 0.26 mm in the year prior to wearing NaturalVue MF. With
NaturalVue MF, the 19 children who have worn the lens for at least
one year demonstrated an axial length change of 0.20 ± 0.19 mm in
one year. This level of axial length growth in these
fast-progressing children wearing NaturalVue Multifocal is very
encouraging.
Combining Dr. Aller’s data with previous studies on NaturalVue
Multifocal, the average follow up period was 12 months, with some
children reaching 36 months of NaturalVue Multifocal wear in 2018.
On average, 97% of more than 80 children showed a decrease in their
rate of myopia progression, with an average decrease of 0.93
dioptres per year.
“The prevalence of myopia is increasing among children globally
at alarming rates, and identifying better ways to manage myopia has
become a top priority for vision care experts worldwide,” said Dr.
Aller. “The NaturalVue Multifocal data are very encouraging based
on the level of decrease in changes in both refractive error and
expected axial length growth, especially in a group of very fast
progressing myopic children. To achieve more than 1.00 dioptres of
decrease in myopic refractive error change on a prospective basis
after one year is quite remarkable and promising. The unique design
of NaturalVue Multifocal offers intervention for multiple potential
causes of myopic progression, and its availability as a daily
disposable contact lens makes it ideal for use in children. I am
excited to continue this research and follow these children into
their second year of wear.”
NaturalVue® (etafilcon A) Multifocal 1 Day Contact Lens
Indication for Use in Europe and Australia and New Zealand:
NaturalVue (etafilcon A) Multifocal Daily Disposable Soft
(Hydrophilic) Contact Lenses are indicated for daily wear for the
correction of refractive ametropia (myopia and hyperopia) and/or
presbyopia, and myopia progression control in aphakic and/or
non-aphakic persons with non-diseased eyes in powers from -20.00 to
+20.00 dioptres and with non-diseased eyes who may require a
reading addition of up to +3.00D. The lenses may be worn by persons
who exhibit astigmatism of 2.00 dioptres or less that does not
interfere with visual acuity.
About Visioneering Technologies, Inc.
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
received the CE Mark, as well as TGA approval in early 2018. VTI
recently commenced its US market expansion for NaturalVue MF
contact lenses, and has broadened its reach into international
markets in 2018. VTI also sells and plans additional contact lens
products.
Foreign Ownership Restriction:
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 or sales
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. The holders of VTI’s
CDIs are unable to sell the CDIs into the US or to a US person
unless the re-sale of the CDIs is registered under the Securities
Act or an exemption is available. Hedging transactions with regard
to the CDIs may only be conducted in accordance with the Securities
Act.
Forward-Looking Statements:
This announcement contains or may contain forward-looking
statements that are based on management’s beliefs, assumptions and
expectations and on information currently available to
management.
All statements that address operating performance, events or
developments that we expect or anticipate will occur in the future
are forward-looking statements. These include, without limitation,
U.S. commercial market acceptance and U.S. sales of our product as
well as, our expectations with respect to our ability to develop
and commercialize new products.
Management believes that these forward-looking statements are
reasonable when made. You should not place undue reliance on
forward-looking statements because they speak only as of the date
when made. VTI does not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise. VTI may not actually
achieve the plans, projections or expectations disclosed in
forward-looking statements. Actual results, developments or events
could differ materially from those disclosed in the forward-looking
statements
1 Cooper, J, O’Connor, B, Watanabe, R, Fuerst, R, Berger, S,
Eisenberg, N, & Dillehay, SM. Case Series Analysis of Myopic
Progression Control With a Unique Extended Depth of Focus
Multifocal Contact Lens. Eye & Contact Lens. 44(5):e16-e24,
September 2018
2 O’Connor, B, Jeruss J, Aller T, Dillehay SM. Myopia Management
with A Unique Extended Depth of Focus Contact Lens: A Case Series
Analysis. Paper presented at Global Specialty Lens Symposia.
January, 2018.
3 Smith MJ, Walline J. Controlling myopia progression in
children and adolescents. Adolesc Health Med Ther.
2015;6:133–140.
4Lam AK, Chan R, Pang PC. The repeatability and accuracy of
axial length and anterior chamber depth measurements from the
IOLMaster. Ophthalmic Physiol Opt. 2001;21(6):477-483.
MKT-ANZ-PR1
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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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