ATLANTA–(BUSINESS WIRE)–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
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.
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.
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.