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FDA Approves First Contact Lens to Slow Myopia Progression in Children

The approval was granted to CooperVision. 

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The U.S. Food and Drug Administration has approved the first contact lens indicated to slow the progression of myopia in children between the ages of 8 and 12 years old.

The FDA granted approval of MiSight, a single-use disposable soft contact lens, to CooperVision Inc.

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“Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Myopia is the most frequent cause of correctable visual impairment worldwide, the FDA noted in a press release announcing the approval. It is common in children and tends to increase as they get older.

CooperVision said in its own press release that MiSight is “the cornerstone of a comprehensive myopia management approach” that it will offer.

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“We can’t overstate the importance and potential impact of this landmark decision on children’s vision, especially considering the rise in myopia’s severity and prevalence in the U.S. and worldwide,” said Daniel G. McBride, president of CooperVision. “Eye care professionals who embrace this breakthrough approach will improve the quality of life and eye health for so many children.”

The product will launch in the U.S. as part of a CooperVision myopia management initiative beginning in March 2020, according to the company’s release. The lens “is already being successfully worn by thousands of myopic children in other parts of the world, including Canada, the United Kingdom, Spain and Australia, where age ranges for initial fitting may vary.”

MiSight “has been recognized as one of the most innovative developments in eye health by the likes of the British Contact Lens Association and international industry media,” according to the release.

The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.

The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens.

The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.

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Additionally, to estimate the rate of vision-threatening corneal infections among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eyecare clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.

As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.

Since launching in 2014, INVISION has won 23 international journalism awards for its publication and website. Contact INVISION's editors at editor@invisionmag.com.

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Here’s Where Optometrists Earn the Most … And Here’s Where They Earn the Least

Forbes analyzed U.S. Bureau of Labor Statistics data.

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Forbes has released an analysis of how much optometrists earn, on average, in each state.

Nationally, the average OD salary is $119,980 per year, according to the report, which is based on data from the U.S. Bureau of Labor Statistics. That’s well above the average of $51,960 a year for all occupations.

Forbes found that the highest-paid optometrists are in North Dakota, where the average pay is $175,090 per year.

The publication noted that a low supply of ODs likely factors into North Dakota’s high pay. There are only 160 optometrists in the state.

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The lowest-paying state for optometrists is Utah, where the average OD makes $74,490. That’s a significant drop from 2013, when the average Utah optometrist made $118,050.

For more information on how eyecare pros live and work, check out INVISION’s 2019 Big Survey.

See the full list at Forbes

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Eye Health Firm Raises $25M, Plans to Expand Sales Team

It’s expanding its ForeseeHome AMD Monitoring Program.

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MaNASSAS, VA — Notal Vision Inc., a privately held ophthalmic diagnostic services company, announced that Ganot Capital is extending the recent funding round to $25 million.

The continued investment will enable Notal Vision to support the commercial growth of the company’s current service, ForeseeHome AMD Monitoring Program, as well as further research and development efforts for pipeline technologies. The company is focused on “advancing eyecare with precision medicine by extending disease management from the clinic to the home,” according to a press release.

“Pursuing additional funding has allowed us to expand our ForeseeHome field-based sales team,” said CEO Kester Nahen. “We have a proven model that includes low-cost medical devices, an effective artificial intelligence (AI)-driven decision support solution, and a dependable clinical patient engagement platform. With the additional investment, we believe we will be able to prove that partnering with accounts as an extension of their practice will drive deeper adoption of our home diagnostic services.”

The company is also funded to continue development of the Home OCT platform, according to the release. The company noted that the platform received FDA Breakthrough Device status at the end of 2018 and that efforts to establish reimbursement are under way.

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The home-based OCT “will help address the high unmet monitoring need for physicians and their patients alongside anti-VEGF therapy,” according to the release.

“Notal Vision is uniquely positioned to continue to lead the ophthalmic home diagnostic services market,” said Guy Kastav, chairman of the board of Notal Vision. “Ganot Capital is an investment company dedicated to improving quality of life for senior citizens. Ganot Capital believes it’s important to help Notal Vision succeed in their mission to help prevent blindness through age-related retinal diseases.”

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Safilo Group Acquires 70% of Blenders Eyewear

Chase Fisher will remain as CEO of Blenders.

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Safilo Group announced the acquisition of a 70 percent stake in the equity of California-based Blenders Eyewear LLC.

Safilo purchased the stake from Chase Fisher, the company’s founding entrepreneur and full owner.

Launched in San Diego, Blenders Eyewear “has built an advanced e-commerce platform with unique digital and social media skills, which has achieved fast and profitable growth thanks to its world-class digital capabilities,” according to a press release. The company generates about 95 percent of its business through its proprietary direct-to-consumer e-commerce platform, more recently complemented by the opening of the first Blenders flagship store in San Diego.

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Blenders Eyewear’s products “are inspired by the California active and progressive lifestyle and offer a compelling price-to-value eyewear proposition, particularly appealing to a broad range of consumers with a focus on Millennials and Generation Z, both female and male,” according to the release.

The brand has fueled its growth through highly social marketing strategies, partnering with influencers, athletes, and lifestyle enthusiasts and arranging product collaborations.

In 2019 the company expects to reach profitable net sales of approximately $42 million, all generated in the U.S. and up around 40 percent compared to the previous year.

Angelo Trocchia, Safilo’s CEO, said: “We are thrilled to welcome to Safilo an inspiring brand like Blenders Eyewear, a fast-growing e-commerce-powered business at the forefront of the latest direct to consumer and omni-channel capabilities, which will enrich our proprietary portfolio with new strong skills and a particular focus on our key US market.”

Chase Fisher, founder and CEO of Blenders Eyewear, said: “This marks a huge step forward for Blenders and we’re excited to be part of Safilo to reach a wider marketplace. Safilo’s product know-how and global distribution capabilities are the perfect complement to our digitally native business model, opening up worldwide expansion potential. We’re on a mission to build a thriving global community that inspires people to live in forward motion.”

Safilo acquired the 70 percent controlling interest in the company, based on a total value on a cash and debt free basis  equal to $90 million. The cash consideration to be paid at closing is subject to customary price adjustments.

Fisher will retain full ownership of 30 percent of the shares and will remain CEO of Blenders Eyewear, which will continue to run out of its San Diego home.

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