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TGA clears latest soft contact lens for myopia control

Australian eyecare professionals now have access to MYLO, one of the world’s few soft multifocal contact lenses specifically for myopia control, after regulators approved the product earlier this month.

Manufactured by Spanish contact lens company mark’ennovy, in conjunction with the Brien Holden Vision Institute (BHVI), MYLO was cleared by the Australian Therapeutic Goods Administration on 6 June, making it the latest addition to the expanding suite of myopia treatments available to optometrists.

Following European market approval in March, this latest milestone means the company can locally market the silicone hydrogel monthly replacement contact lens as a medical device specifically for myopia management.

According the two-year results of a randomised clinical trial published in May, MYLO slowed myopia progression by 32%, as determined by spherical equivalent refractive error, and axial length elongation by 25%, when compared to children wearing single vision contact lenses.

The study involved 508 myopic Chinese children aged from 8-13, separated into five groups. As well as MYLO, in Australia this category now consists of CooperVision’s MiSight 1 Day multifocal soft contact lens, the pioneering lens of the segment available in Australia since 2016, and Visioneering Technologies’ NaturalVue Multifocal 1 Day, available locally since late 2018.

MYLO was developed under an exclusive licensing agreement between mark’ennovy and BHVI, and is powered by BHVI’s extended depth of focus (EDOF) technology.

Mark’ennovy is also manufacturing and marketing the lens for presbyopes under the name EDOF.

According to Mr Chris Harous mark’ennovy managing director Asia Pacific, Brisbane-based Capricornia Contact Lens would distribute MYLO. He said eyecare professionals could now expect to see increased promotion, conference exhibitions and workshops promoting the product.

“TGA approval for MYLO was absolutely critical to ensure eyecare professionals and their patients have complete confidence, trust that MYLO is approved as a myopia managent medical device,” Harous said.

“Its wide range of parameters supports a more personalised contact lens fit, allowing MYLO to be carefully calibrated to your eye at any age or stage of myopia management.”

He added: “Our signature range of diameters and base curves for the most precise contact lens fit differentiate our myopia managent lens from any other on the market.”

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