NAGOYA, Japan, 21st November 2019 – Menicon Co., Ltd announced Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear have received PMA approval from the U.S. Food and Drug Administration and are indicated for use in the management of myopia in non-diseased eyes when prescribed and managed by a qualified eye care practitioner.
Menicon is committed to supporting the eye care professionals and assisting in addressing the growing global incidence of myopia, and has tailored its market access strategy accordingly.
Menicon’s market approval approach is intended to provide the most appropriate indication for use to the eye care professionals, as a means to afford the best product or service choices for their patients.
Menicon continues to review and evaluate the global myopia marketplace.
With this addition, Menicon is the only company in the world offering both orthokeratology and soft contact lens devices specifically approved for myopia control in Europe
NAGOYA, Japan, 16 October 2019 – Menicon Co., Ltd announces it has entered into a definitive agreement with Visioneering Technologies, Inc (VTI) to market and sell VTI’s NaturalVue® MF contact lenses in Europe. NaturalVue® MF (etafilcon A) center-distance multifocal daily disposable soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive myopia and myopia progression control in non-aphakic persons with non-diseased eyes in powers up to -12 diopters and will be commercialized by Menicon in Europe as Menicon Bloom™ Day under the Menicon Bloom™ Myopia Control Management System.
The above announcement shortly follows the recent launch of Menicon Bloom™ Myopia Control Management System in the Netherlands last June, which featured the initial introduction of Menicon Bloom™ Night, the first and only CE-approved orthokeratology contact lens in Europe for myopia control. With the addition of Menicon Bloom™ Day to Menicon Bloom™ Myopia Control Management System, Menicon is the only company in the world offering both orthokeratology and soft contact lens devices specifically approved for myopia control in Europe and demonstrates the company’s continued commitment to the field of myopia control. Full launch of Menicon Bloom™ Myopia Control Management System will be expected in major European markets throughout 2020.
Dr. Hidenari Tanaka, CEO, Menicon Co., Ltd., commented: “We are delighted with the addition of VTI’s NaturalVue® MF daily disposable contact lenses to our Menicon Bloom™ Myopia Control Management System. We are committed to building a strong and flexible product portfolio within our Menicon Bloom™ Myopia Control Management System in order to offer eye care professionals worldwide a wide range of on-label, approved treatment options for myopia control. We believe the increasing levels of myopia reported across the world requires a comprehensive and educated response and we have identified this as a major initiative within our development programs.”
* “Bloom”, “Bloom Night” and “Bloom Day” are trademarks of Menicon Co., Ltd.
Menicon Co., Ltd. (7780: Tokyo), founded by Mr. Kyoichi Tanaka in 1951, is Japan’s first and largest contact lens manufacturer, and now is represented in over 30 countries. Menicon is a manufacturer dedicated to all areas of soft and gas permeable contact lens-related businesses including manufacturing, sales, export and import of contact lenses and other medical goods; manufacturing and sales of medical instruments; sales of medical supplies; and research and development of intraocular lenses.
For more information, visit: www.menicon.com.
Visioneering Technologies Inc. (ASX: VTI) is an innovative eye care company committed to redefining vision. Since its founding in 2008, Visioneering has brought together clinical, marketing, engineering, manufacturing and regulatory leaders from top vision care businesses to provide new solutions for presbyopia, myopia and astigmatism. Headquartered in the US, Visioneering designs, manufactures, sells and distributes contact lenses. Its flagship product is the NaturalVue® MF daily disposable contact lens, and VTI has expanded its portfolio of technologies to address a range of eye care issues. The company has grown operations across the United States, Australia and Europe and is expanding into Asia with a focus on markets with high rates of myopia.
To learn more, please visit: www.vtivision.com
Menicon Co., Ltd. (Head office: 3-21-19, Aoi, Naka-ku, Nagoya; President and CEO: Hidenari Tanaka) is pleased to announce that on Tuesday, October 1, 2019, it acquired a 100% equity stake in the FINEKO Group (Headquartered at the head office of SOLEKO S.p.A.: Via Ravano sce – Pontecorvo (FR); Representative: Guido Carnacina; number of employees: approx. 85), which owns SOLEKO S.p.A., an Italian company which manufactures and sells contact lenses and contact lens care products, making the group its wholly owned subsidiary.
Founded in 1975 as a company operating under the wing of the FINEKO Group, SOLEKO S.p.A. manufacturers and sells contact lenses and contact lens care products, mainly targeting the Italian market.
The disposable contact lens market in Italy is the second largest in the booming European market after the UK. One-day disposable contact lenses, in particular, have seen robust growth in the Italian contact lens market. Menicon has already established a solid business footing in the European market, with 60% of its overseas sales being generated in the region. The latest acquisition of the FINEKO Group is designed to strengthen Menicon’s marketing networks in Europe by adding a promising new market, Italy. In addition, SOLEKO S.p.A. develops and manufactures unique contact lens care products. By selling these products through the Menicon Group’s marketing networks, the Group also expects to enjoy synergy effects by reinforcing its group-wide portfolio for contact lens care products.
As a result of the latest share acquisition, Menicon now owns a sales subsidiary in a major European contact lens market. Consequently, the company has established a platform through which it will be able to provide more customers with the “Miru” (overseas brand name) line of disposable contact lenses. This will expand and strengthen its product lineup. Menicon intends to step up its global operations in an endeavor to enhance the quality of life of its end users by supplying its contact lenses to as many people as possible.
Menicon Co., Ltd. announced on May 24 the launch of the Menicon Bloom Myopia Control Management System, a holistic approach for myopia control management. The launch features the initial introduction of Menicon Bloom Night, an orthokeratology contact lens therapy for myopia control management.
Myopia, also known as near- or short-sightedness, is the most common refractive error and the major cause of vision impairment worldwide. It affects approximately 30% of the world’s population and its prevalence has been forecast to affect about 50% of the world’s population by 2050. The prevalence of myopia in young adolescents has been increasing in recent decades to about 30% in industrialized societies of the West and epidemic levels of over 90% in some parts of Far East Asia. Globally, it is recognized as a significant public health concern associated with increased ocular-related morbidity and considerable healthcare costs.
Menicon Bloom Night therapy involves the overnight wear of a specially designed reverse geometry orthokeratology contact lens, manufactured in hyper oxygen-permeable Menicon Z rigid material that ensures optimal corneal oxygenation for comfortable and safe contact lens wear. The treatment temporarily changes the shape of the cornea, which results in reduction of refractive error, thus eliminating the need to wear contact lenses throughout the waking hours after lenses are removed. The new corneal shape provides a particular optical path for incoming light that counters the ocular growth response associated with myopia development. Through this mechanism, Menicon Bloom Night is indicated for the correction of refractive myopia and for control of myopia when prescribed and managed by a qualified eye care professional.
Menicon Bloom Night contact lenses have been reviewed and validated via numerous comprehensive, peer-reviewed studies related to myopia control management. Menicon Bloom Night therapy has proven to be well-accepted by parents and to improve children’s self-esteem in terms of physical appearance, participation in activities, academic performance and peer perception. 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.
The fitting of Menicon Bloom Night is optimized by the use of Easyfit software, a sophisticated, user-friendly tool which accurately guides the eye care professional through the fitting process. Additionally, a specially designed mobile phone application, Menicon’s Virtual Dr., has been developed to enhance the monitoring and communication process between eye care professionals and patients. Menicon Bloom Night is only available for certified eye care professionals. With the launch of this groundbreaking myopia care therapy, Menicon has become one of the few companies to have devices officially approved for myopia control management in Europe and demonstrates the company’s continued commitment to the field of myopia control.
Menicon Bloom Night will be launched initially in The Netherlands, followed soon thereafter with launches in other European markets. Further information about the product and availability will be forthcoming soon.
Dr. Hidenari Tanaka, CEO, Menicon Co., Ltd, commented: “We are delighted with the major breakthrough achieved with the approval and launch of our Menicon Bloom Myopia Control Management System. We are confident that our continuing commitment to myopia control management will position Menicon as a key contributor in this field and strengthen our position as a global vision care company. It is our belief that the growing prevalence of worldwide myopia progression requires a comprehensive and educated response and we have identified this as a major initiative within our development programs.
As a pioneer of contact lenses, we will develop our myopia control business based on our accumulated technology, products and services and contribute to society by supporting eye care professionals in managing the fast growing incidence of myopia”
Menicon Co., Ltd. (7780: Tokyo), founded by Mr. Kyoichi Tanaka in 1951, is Japan’s first and largest contact lens manufacturer, and now is represented in over 30 countries. Menicon is a manufacturer dedicated to all areas of soft and gas-permeable contact lens-related businesses including manufacture, sales, export and import of contact lenses and other medical goods; manufacture and sales of medical instruments; sales of medical supplies; and research and development of intraocular lenses. For more information, visit www.menicon.com.
* “Bloom”, “Bloom Night”, “Menicon Z” and “Easyfit” are trademarks of Menicon Co., Ltd.
Current Kakamigahara Factory (single-story)
After expansion, the factory will have second and third floors.
At Menicon Co., Ltd., construction has been decided to initiate on December 1, 2018, to add the second and third floors to the current single-story Kakamigahara Factory (Kakamigahara-shi, Gifu), where our daily disposable contact lenses are manufactured, to increase our production volume.
In operation since March 2015 to produce “1DAY Menicon PremiO,” Menicon’s daily disposable contact lenses, the Kakamigahara Factory was originally designed to add floors vertically, when required to “increase production volume in the future” and/or “improve efficiency of traffic lines of materials and people in the factory.” The construction for expanding the floors will start in December. We can safely continue production of contact lenses on the first floor during construction because of the double steel beam structure of this building.
This construction is scheduled to be completed in the spring of 2020. A total of 15 lines will be installed, an increase from the current three lines. Our production lines will be sequentially added, targeting an annual production capacity of over 500 million lenses. By increasing the production volume and product portfolio, we aim for greater sales in the daily disposable contact lens market in Japan and the rest of the world, which is expected to grow.
<Expansion of the Factory Floors>
In this construction, the building will be expanded not horizontally but vertically, by adding the second and third floors. The first floor, where we currently operate, was originally designed to accommodate added floors; therefore, the first floor roof will not be removed, and no anchor bolts will be installed on the roof during construction. Thus, we can continue production on the first floor without being affected by waterproofing works, vibration, or noise. By adding the floors, we can construct the warehouse to store intermediate and final products in the second and third floors. By automating the storage and retrieval processes, the traffic lines of materials and people in the factory will be more efficient.
By issuing convertible bonds in June 2018, we raised a fund of JPY 8 billion. A part of this fund will be spent on the construction of the additional floors of the factory, because an increase in the production volume of daily disposable contact lenses, which are expected to grow in the contact lens market in Japan and abroad, is believed to lead to further growth of our group.
<Production and Sales Volume>
Currently, our production capacity is 90 million lenses per year (with three lines). After the introduction of all of the lines (15 lines), we seek to produce over 500 million lenses, corresponding to approximate sales of JPY 25 billion (based on the assumption that we will produce contact lenses similar to our current daily disposable products).
We are pleased to announce the full-scale launch of the improved version of “Miru 1month Menicon”, our monthly replacement silicone hydrogel lens series, into the US market. Until now, “Miru 1month Menicon” has been marketed mainly in Europe, where it has been well received.
Since entering the European market with this product in 2007, we have steadily increased the number of export destinations and the lens is now used in more than 30 countries. We have also increased the number of product variants, starting with products for myopia/hyperopia and then adding those for astigmatism followed by bifocals. We obtained FDA approval in February 2018 for this lens series and are planning full-scale launch of the products in the US this fall or later.
The redesigned products for the US market, namely “Miru 1month Menicon” for myopia/hyperopia, “Miru 1month Menicon Toric” for astigmatism (the product is called “Miru 1month Menicon Astigmatism” in Europe) and bifocal “Miru 1month Menicon Multifocal” are made from materials similar to those used in the manufacture of “2week Menicon PremiO”, which has the second largest share of the Japanese market. Focusing on the eye health of users, we supply monthly replacement lens products which are highly safe and comfortable to wear.
* The photograph above shows the product packages for the US market. Regarding the “Miru 1month Menicon” series, marketed mainly in Europe, there will be no changes to the packaging.
Features of “Miru 1month Menicon” Series:
(1) High Oxygen Permeability
In this series, high oxygen permeability (oxygen transmission coefficient: Dk/t＝161*) has been achieved to safeguard the eye pupil while the lenses are being worn.
*Dk/t (a unit measured as): × 10-9 (cm/sec)･(mLO2/(mL ×mmHg) (in case of Pwr-3.00D)
Particularly for products designed to correct astigmatism and for bifocals, where lens thickness tends to increase, we are dedicated to ensuring wearer comfort and safety by adopting the most advanced and safety-oriented lens
(2) Excellent Surface Properties
In the “Miru 1month Menicon” series, we adopted the same surface treatment technology used in the manufacture of the “Miru 1month Menicon” series already marketed outside the US, having achieved high wettability and excellent antifouling properties against bacteria or protein/oil-based dirt, while maintaining satisfactory oxygen permeability.
With the launch in the US of “Miru 1month Menicon”, “Miru 1month Menicon Toric” and “Miru 1month Menicon Multifocal”, which feature a well-balanced lens design and materials that have already demonstrated their merits in the marketplace, we are convinced that we can provide products that are comfortable to wear, safe and hygienic to support eye health in the US market as well as in other markets. We are also aiming at increasing our share of the replacement lens (periodic exchange lenses) market in the US, which is reported to be worth 350 billion yen.**
**Source: research by Euromonitor International
Menicon Co., Ltd. today announced the official launch of silicone hydrogel daily disposable contact lens “Miru 1day UpSide,” a version of “1DAY Menicon PremiO” sold overseas.
“Miru 1day UpSide” is a silicone hydrogel daily disposable contact lens marketed in Japan under the name of “1DAY Menicon PremiO.” 1DAY Menicon PremiO is characterized by “SMART TOUCH” technology, in addition to our most advanced material, and has been widely used in Japan since its launch in December 2016.
UpSide means “looking up.” This naming is intended to draw intuitive appeal to one of the characteristics and the best feature of the product, the SMART TOUCH package that “allows users to wear the lenses without touching the inner surface of the lens because the outer surface of the lens is placed upward (it is placed downward in the package of other products) when users open the package.” Our questionnaire survey has revealed that this SMART TOUCH, both the feature and the name, has been favorably accepted. Our goal is to have the product accepted in the global market for its feature that is expressed in the brand name.
Further, the material used for “Miru 1day UpSide” is silicone hydrogel that is highly oxygen-permeable and is as soft as other existing hydrogel materials.
“Miru 1day UpSide” will be launched first in Europe; then, the sales market will be expanded successively. We will strive to increase the share for daily disposable lenses in the European market worth JPY 150 billion*.
*estimated by Euromonitor
Six particular features of “Miru 1day UpSide (1DAY Menicon PremiO)”
Users do not need to check the sides of lenses. The package allows users to pick up the lenses without touching the inner surface of the lens (SMART TOUCH), which enables easy wearing.
(2) Oxygen permeability
“Miru 1day UpSide” has oxygen permeability that ensures the safety of the pupil when the product is used as a daily disposable lens.
Oxygen permeability: 91×10?9(cm/sec)・(mLO2/(mL×mmHg)) (in case of -3.00 D)
Oxygen-permeable silicone hydrogel lenses are generally hard and not comfortable to wear. However, “Miru 1day UpSide” is sufficiently oxygen permeable and also has achieved softness comparable to that of existing lenses. This well-balanced material offers users comfort when wearing the lens.
Featuring new plasma technology, “Miru 1day UpSide” prevents adhesion of dirt on the surface, which prevents reduction in the performance of the lenses and also ensures lower friction on the surface of the lenses. This lower friction contributes to a natural feeling when users wear the lenses.
(5) Design of the Lens
Generally, contact lenses for excessive myopia tend to be thicker, particularly in the peripheral part, which often compromises the feeling of comfortable wearing. However, our product is designed to be evenly thin, even in the peripheral part, regardless of the optical power of the lens. As such, comfort during the use is maintained.
(6) UV protection
“Miru 1day UpSide” is made of materials that cut UV light and protects the pupil from UV light.
UVA protection rate: 84%
UVB protection rate: 96% (-3.00 D)
By bringing this daily disposable contact lens that has realized these highly particular features to broader overseas markets, we hope to offer contact lenses that contribute to a better lifestyle for more users.