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mark’ennovy obtains European clearance for myopia control contact

27/03/2019By Myles Hume
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Spanish contact lens manufacturer mark’ennovy has secured European regulatory approval for its myopia control multifocal soft contact lens, MYLO.

The product – developed in conjunction with the Sydney-based Brien Holden Vision Institute (BHVI) – could be made available to Australian optometrists as soon as June, with the European clearance expected to pave the way for an expedited Australia Therapeutic Goods Administration (TGA) approval process.

The company can now to market the silicone hydrogel monthly replacement contact lens as a medical device specifically for myopia management within the European Economic Area.

With other markets expected to follow, MYLO will directly compete with CooperVision’s MiSight 1 Day multifocal soft contact lens, the pioneering lens of the segment widely available in Australia since 2016, and Visioneering Technologies’ NaturalVue Multifocal 1 Day, available to local optometrists since late 2018.

Chris Harous
Chris Harous
“The addition of MYLO specifically designed for myopia management is a genuine opportunity for Australian optometrists to now provide another premium treatment option in what is a high growth area for the future of optometry”
Chris Harous, mark’ennovy.

MYLO was born out of a September 2017 exclusive licensing agreement between mark’ennovy and BHVI, which combined BHVI’s advanced optical designs and mark’ennovy’s manufacturing capabilities to form a portfolio of new soft contact lenses for myopia and presbyopia.

According to mark’ennovy, MYLO is powered by BHVI’s extended depth of focus (EDOF) technology. The company is also marketing the lens for presbyopes under the name EDOF.

The design has been shown to slow myopia progression by 31% in children after one year, according to BHVI. The two-year efficacy results are being discussed and are due to be published.

mark’ennovy Asia Pacific managing director Mr Chris Harous said the European clearance will help accelerate MYLO through the TGA approval process, with indications it will be available in Australia by mid-June.

For optometrists who want to use the lens in myopic patients sooner, Harous said the EDOF +1.50 addition for presbyopes could be prescribed ‘off-label’, with many eyecare professionals already using other multifocal soft contact lenses in a similar fashion.

“The addition of MYLO specifically designed for myopia management is a genuine opportunity for Australian optometrists to now provide another premium treatment option in what is a high growth area for the future of optometry,” Harous said.

Professor Padmaja Sankaridurg, head of BHVI’s ‘Global Myopia Centre’, said MYLO’s EDOF design was key to its performance in controlling myopia.

“The lens design provides a signal to slow eye growth by degrading quality of the image behind the eye and therefore reducing the risk of the eye growing posteriorly,” she said.

MYLO will be available as a monthly replacement in a broader range of base curves and diameters.

 

More reading:

Mark’ennovy partners with Australian contact lens company
Customised contact lens manufacturer launches in Australia

 






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