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Menicon obtains first European approval for OrthoK lens

05/06/2019By Callum Glennen
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The world’s first orthokeratology (OrthoK) contact lens to secure European regulatory approval for myopia control will be available to the Australasian market early next year.

Japanese contact lens manufacturer Menicon officially launched its Bloom Myopia Control Management System on 24 May after European regulators cleared its Bloom Night OrthoK lens for myopia control management.

The milestone sees Menicon become one of the few contact lens manufacturers to have devices with a myopia control indication in Europe, with the company claiming its product is the first and only among OrthoK products.

The reverse geometry OrthoK lens is manufactured in hyper oxygen-permeable Menicon Z rigid material, which is said to ensure optimal corneal oxygenation for comfortable and safe contact lens wear.

The technology helps form a new corneal shape that provides a particular optical path for incoming light that counters the ocular growth response associated with myopia. It is through this mechanism that the lens is indicated for both the correction of refractive myopia and myopia control when prescribed and managed by a qualified eyecare professional.

Mark Whibley
Mark Whibley
“Bloom will need [Australian] Therapeutic Goods Administration approval but we expect this to be a fast process with the certificates we have available”
Mark Whibley, Menicon

“With the accumulation of long-term and comprehensive scientific evidence over the years, Menicon Bloom Night has met the highest standards of safety, efficacy and quality required to grant the treatment CE approval for myopia control management in Europe,” a company statement said.

Menicon Australia director Mr Mark Whibley told Insight the product would now be available to Australian and New Zealand market early next year.

“Bloom will need [Australian] Therapeutic Goods Administration approval but we expect this to be a fast process with the certificates we have available,” he said. “Currently it is being progressively rolled out to various European countries.”

“Bloom will be presented as a complete package of both the contact lenses, plus it will be packaged with Bloom branded care solutions, making it a total family of products for patients seeking myopia control.”

Bloom Night will only be available for certified eyecare professionals and will be launched initially in The Netherlands, closely followed by other European markets.

The contact lens will be fit using the company’s proprietary software package, Easyfit. Additionally, Menicon’s specially designed mobile app, Virtual Dr., has been developed to enhance the monitoring and communication between eyecare professionals and patients.

Carl Zeiss
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Visioneering Technologies opens myopia control contact lens to Australian market
mark’ennovy obtains European clearance for myopia control contact
Myopia: A new opportunity
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