VTI Press Release: Visioneering Technologies, Inc. Announces FDA 510K Clearance for NaturalVue™ Multifocal 1 Day Contact Lens
FOR IMMEDIATE RELEASE:
Visioneering Technologies, Inc. Announces FDA 510K Clearance for NaturalVue™ Multifocal 1 Day Contact Lens
December 1, 2014
ATLANTA, GEORGIA – Visioneering Technologies, Inc. (VTI) announced today that VTI’s new multifocal contact lens, NaturalVue™ (etafilcon A) Daily Disposable Soft (Hydrophilic) Multifocal Contact Lens has been issued a 510(k) clearance. NaturalVue Multifocal 1 Day Disposable contact lenses are designed to provide correction for presbyopia, the age-related loss of ability to see objects up close. Presbyopia affects nearly all people over the age of 401. NaturalVue Multifocal 1 Day contact lenses deliver excellent vision across the entire range, from near to distance and everything in between, and with their Universal ADD feature, NaturalVue Multifocal 1 Day Disposable contact lenses are simple to fit2.
The over-40 population represents the first group that has ‘grown up’ wearing contact lenses, and they expect to have the same outstanding vision and comfort that soft contact lenses have given them for years, even as they age. Unfortunately, many eye care practitioners and their presbyopic patients are not satisfied with today’s selection of contact lenses for presbyopia. In a study conducted by Jobson Optical Research in 2013 with nearly 400 respondents, 99.5% of eye care practitioners reported that their patients experience compromises with the multifocal contact lenses on the market today3. According to eye care practitioners, as many as 85% of patients experience compromised vision in at least one area of vision (near, intermediate, distance)3. NaturalVue Multifocal 1 Day Disposable contact lenses represent smarter thinking in presbyopia solutions: Unlike any other multifocal contact lens on the market, the science inside NaturalVue lenses is inspired by how a camera aperture channels light and how neural factors enhance vision. This new, revolutionary patented approach has added a new power to fight presbyopia - ‘brain power’. The design works with the brain to automatically help eyes focus when and where they need to – which gives the patient effortless sharp vision at every distance, in order to see more naturally4.
Additionally, most eye care practitioners report that multifocal contact lenses are complicated to fit and can lead to frustration for both the fitter and the patient. NaturalVue Multifocal 1 Day Disposable Contact Lenses are designed to be easy to fit, similar to a spherical lens5: One base curve, one diameter, and most importantly, one “Universal” ADD, which accommodates up to 3.00D of equivalent near power, makes fitting NaturalVue™ easy and fast5. This ultimately translates into benefits for both the practice and patient according to Dr. Sally Dillehay, VTI’s Vice President of Clinical and Regulatory Affairs. “The unique, patented NaturalVue multifocal is designed to reduce the number of office visits, the number of lenses used, and the amount of time required for a successful multifocal fit. The response from patients in clinical trials has been very positive, especially in regards to the crisp, clear distance vision along with outstanding vision for intermediate and near visual tasks. Patients report being able to complete over 91% of their normal visual tasks with the NaturalVue 1 Day Disposable Multifocal without the need to use supplemental reading glasses or magnifiers5. This is a significant improvement for patients who don’t want to have to search for reading glasses just to be able to read or use their cell phones. ”
With NaturalVue contact lenses, the patients will have spectacle level visual acuity and stereoacuity (depth perception) for optimal vision performance with little compromise5. And because this remarkable new contact lens is a daily disposable, it’s fresh, clean and comfortable every day.
The company plans to launch NaturalVue Multifocal 1 Day Disposable Contact Lenses in the first quarter of 2015. For more information, contact Dr. Sally Dillehay at VTI or through email at firstname.lastname@example.org .
Dr. Sally Dillehay or Layna Mendlinger (770) 521-4358,
or email@example.com (RE: NaturalVue FDA Clearance)
About Visioneering Technologies, Inc.
Visioneering Technologies Inc. (VTI), headquartered in Alpharetta, Georgia, is an innovative new company dedicated to redefining vision. With a portfolio of technologies to address serious eye issues such as presbyopia and myopia, the company uses creative and differentiated design approaches to develop products that enhance practitioner and patient experiences.
VTI original optical designs were created by Dr. Richard A Griffin, an optometrist and aerospace engineer, who has spent 20 years developing VTI’s unique lens designs. VTI lens designs have been awarded fourteen issued patents worldwide since 2002 that address the need for a treatment for presbyopia in the underdeveloped, on-eye/in-eye categories.
Strength in science, an entrepreneurial culture, and the ability to bring technology to life make Visioneering Technologies a company to watch.
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1Schachet, J., Kading, D., Lowinger, S., Schaeffer, J., & Sindt, C. (2014). Multifocals: The New Standard of Care (Part 1 of 2). Contact Lens Spectrum.
2 Data on file, 2014
3 Data on file, 2014
4 Data on file, 2014
5 Data on file, 2014