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LASIK Should Be Banned, Says Former FDA Adviser

He regrets voting to approve the treatment.

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A retired U.S. Food and Drug Administration adviser says LASIK eye surgery should be removed from the market.

Morris Waxler voted to approve to treatment, but now wishes he hadn’t, CBS News reports. He has re-examined the data.

“Essentially we ignored the data on vision distortions that persisted for years,” he told CBS.

His analysis suggests that 10 percent to 30 percent of patients experience complications. He asked the FDA in 2011 to issue a voluntary recall of the treatment, but the FDA declined to do so.

The FDA recently told CBS that it “has not found any new safety concerns associated with LASIK devices.”

CBS News quoted several patients saying they’d been harmed by LASIK.

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Abraham Rutner, for example, said that he had double vision and that “around the lights [was] like having starbursts.” He notes, however, that his vision is improved by approximately 90 percent.

Experts say pre-surgical screening is crucial to avoiding LASIK complications.

The key lies in “knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur told CBS News.

The FDA has issued an advisory on risks and how to find find the right doctor for LASIK.

Read more at CBS News

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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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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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Sunglass Maker to Cut 295 Jobs and Close Most of Its Daytona Beach Operations

It’s being integrated into the Luxottica profile.

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Sunglass maker Costa Del Mar plans to close most of its operations in Daytona Beach, FL, with 295 jobs to be cut in the process.

The first job eliminations are set to take place on Feb. 7, the Daytona Beach News-Journal reports. Costa employs 350 people in Daytona Beach currently.

In a letter to state, county and city officials, the company cited “changing business needs” as the reason for its decisions.

“Certain sales and marketing functions” will remain in Daytona Beach, the newspaper reports, quoting the latter.

The layoffs will continue through the end of September.

WESH-TV reports that jobs are being moved to New York and California.

Costa was acquired by Essilor in 2014. Last year, Essilor merged with Luxottica, with the combined company being called EssilorLuxottica.

According to WESH, the company said that Costa is “an incredibly special and unique brand” and that “we see great growth potential for it in the future.”

“EssilorLuxottica’s decision to integrate Costa into the Luxottica profile will allow the brand to fully leverage on Luxottica’s strengths in everything from product innovation to manufacturing to supply chain to distribution networks, helping it reach its full potential,” the company said in the statement.

Read more at the Daytona Beach News-Journal

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