Johnson & Johnson Vision Receives FDA’s Breakthrough Device Designation

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JACKSONVILLE, Fla.—Johnson & Johnson Vision has received the FDA’s “breakthrough device” designation for its myopia control lens, company executives noted on a recent conference call with securities analysts following the announcement of second-quarter financial results. Chris DelOrefice, Johnson & Johnson’s vice president for investor relations, noted the FDA’s action on the company’s myopia lens on the July 16 conference call. DelOrefice said J&J’s contact lens business has had “consistent strong performance” the past four years and the myopia control lens is part of that success. “It’s a franchise we feel very strong about going into the future,” he said.

According to the FDA website, the “breakthrough device” development program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

In November 2019, as VMAIL reported, the FDA approved CooperVision’s MiSight contact lens as the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.

J&J Vision noted in an email message that it was pleased with the FDA’s decision earlier this month.

“We are pleased to have received the U.S. FDA breakthrough device designation for our novel myopia control contact lens, which is being investigated to slow the progression of myopia,” Carlos Taveras, J&J Vision’s communications leader, North America, told VMAIL. “The U.S. FDA breakthrough device designation is providing an interactive and timely review of pivotal clinical trial protocols, along with more frequent communications with the agency throughout the development process. We look forward to continuing to advance our clinical studies, and to collaboratively translate a robust scientific understanding into solutions with the potential to transform the standard of care for myopia.”

In June, Johnson & Johnson Vision announced new clinical research on myopia progression in children and detailed significant child myopia screening and education progress in the Asia Pacific region. The clinical research and public health programs are part of the comprehensive myopia research collaboration with the Singapore Eye Research Institute (SERI) and Singapore National Eye Centre (SNEC), which launched in April 2019.

“Globally, for parents of children with myopia, and eyecare professionals, an important takeaway is the need for myopic patients to receive regular annual check-ups,” said study lead author Noel Brennan, PhD, global lead, myopia control, Johnson & Johnson Vision. “While myopia progression rates will naturally be followed from year to year, it is also important that eyecare professionals consider age of myopia onset and parental myopia.”