Visioneering Technologies (ASX:VTI), a US-based medical device company focussed on developing products that improve vision, has announced receipt of European CE Mark for commercialisation in the European Union of its portfolio of NaturalVue (etafilcon A) brand 1 Day Contact Lenses, including Sphere, Toric, Multifocal and Multifocal Toric.
The company's CE Mark includes an indication for its NaturalVue Multifocal (NVMF) for myopic progression control (the control of progressive nearsightedness). NVMF contact lenses feature VTI’s Neurofocus Optics Technology, which the company says employs an extended depth-of-focus design to address known optical risk factors associated with myopia progression.
“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 Price, CEO of The ADP Consultancy specialising 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 requirements of the Medical Device Directive (MDD 93/42/EEC).
The CE Mark allows VTI to commercialise 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.”