The US Food and Drug Administration has authorized marketing of the first eyeglass lenses in the United States that not only correct nearsightedness in children, they can slow the progression of the condition.

The FDA said Thursday that it had issued marketing authorization for Essilor’s Stellest eyeglass lenses for children ages 6 to 12 who have myopia, also known as nearsightedness, with or without astigmatism.

Myopia is when someone can see objects close-up but their vision becomes blurred when looking at objects farther away, and astigmatism is a condition in which either the eye’s cornea or lens has a different shape than normal, causing blurred vision.

“As a practicing ophthalmologist, I see firsthand the lifelong impact that vision problems can have on an individual,” Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in the agency’s announcement Thursday. “Today’s authorization brings to market a treatment option that may meaningfully reduce the likelihood of severe eyesight issues later in adult life, while also being easier to use and lower risk than the currently authorized devices that slow the progression of myopia in children.”

Myopia typically progresses in school-age children when their eyes are still growing and then levels off around early adulthood. Before the Essilor Stellest authorization, there was only one approved device in the United Staates for slowing the progression of myopia: contact lenses for children ages 8 to 12, according to the FDA.

The eyewear company Essilor, which makes the newly authorized eyeglass lenses and is headquartered in France, said in a news release Thursday that the FDA had designated its product as a “breakthrough device” in 2021. Clinical trial data showed that the Stellest lenses can slow myopia progression by 71% on average over the course of 24 months, compared with single vision control lenses, according to the FDA. And no serious adverse events were reported.

In the coming weeks, Essilor says, it will make the Stellest lens available for eye-care professionals in the United States who could prescribe them.

The newly authorized eyeglass lenses add a significant tool to the nation’s toolbox when it comes to treating nearsightedness in children, said Dr. David Berntsen, professor and chair of clinical sciences at the University of Houston College of Optometry, who was not involved in the development of the lenses.

“The glasses are one of the pieces that have been available everywhere else, except for the United States,” Berntsen said. Similar products have been available in Canada, Europe and Asia.

“When it comes just having a full spectrum of options for treating kids, the glasses add a big piece that we haven’t had in the US,” he said. “The adding in and having a spectacle lens that is now available will be a game-changer in the United States.”

It’s estimated that more than a third of children worldwide were nearsighted in 2023, and this proportion is expected to climb to almost 40% in 2050.

In the coming weeks, Essilor says, it will make the Stellest lens available for eye-care professionals in the United States who could prescribe them. – Benoit Tessier/Reuters

How the lenses work

The FDA says the Essilor Stellest eyeglass lenses have a clear area in the center that is surrounded by rings of tiny raised dots along the periphery of the lens. Those dots can defocus peripheral light, which may help slow the progression of myopia in children.



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