Visioneering Technologies announced receipt of the European CE Mark for commercialization in the European Union of its portfolio of proprietary NaturalVue (etafilcon A) brand 1 Day Contact Lenses, including sphere, toric, multifocal, and multifocal toric. VTI’s CE Mark includes an indication for VTI’s unique NaturalVue Multifocal (NVMF) for myopic progression control (the control of progressive nearsightedness). NVMF contact lenses feature VTI’s innovative Neurofocus Optics Technology, which employs a patented extended depth-of-focus design to address known optical risk factors associated with myopia progression. The innovative NVMF lens design allows it to be used for both myopic progression control and presbyopia.
“It is very exciting that we now have available a CE marked product with indications for both myopic progression control and presbyopia, that provides excellent near, intermediate, and distance vision in a daily disposable multifocal contact lens,” said Andrew D. Price, FBDO(Hons) CL, CEO of The ADP Consultancy specializing in ocular surface/contact lens clinical care, clinical trials and eye care practitioner education in the UK. “For a company the size of VTI to have developed such a uniquely powerful, elegant high-performance product is very remarkable. I look forward to prescribing NaturalVue multifocal lenses to both my adult and school-age patients.”
The CE Mark is awarded by the European Union’s (EU) Notified Body and indicates that a product’s design conforms to the stringent requirements of the Medical Device Directive (MDD 93/42/EEC). The CE Mark allows VTI to commercialize its contact lens products in Europe, as well as to prepare regulatory submissions to launch its products in additional countries, including Australia, New Zealand, Hong Kong, Singapore, and others.
“We are thrilled to have achieved the CE Mark for our contact lenses. This is a tremendous accomplishment, and speaks volumes towards our commitment to making innovative new products available to patients and practitioners worldwide,” said Dr. Stephen Snowdy, CEO of Visioneering Technologies. “VTI is now poised to expand our product availability internationally in 2018, including some Asian countries, where up to 90% of children are burdened with myopia.”
Paediatric myopia progression affects a high percentage of children in industrialized nations. A recent study published in the peer-reviewed journal, Eye and Contact Lens, documented that VTI’s NaturalVue MF lens delivered approximately 96% reduction (average of both eyes) of annualized myopic progression in children aged 6 to 19, with 98.4% of the children showing a decrease in the rate of worsening of their myopia.i