FDA authorizes first eyeglass lenses to slow nearsightedness in children in the US

By Jacqueline Howard, CNN

(CNN) — 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.

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.

A growing body of research suggests that when the quality of an image that the eye’s peripheral retina receives is manipulated – such as through a lens – that may slow eye growth, said Dr. Jeff Walline, professor of optometry at The Ohio State University.

In children with myopia, the eye grows too long, and this causes the image projected on the retina to be poorly focused when they look at a distance. The retina is a layer of tissue at the back of the eyeball that converts images into nerve signals that are sent to the brain, and the peripheral retina is the outer portion, which gives us side vision.

The idea is that “the whole retina regulates eye growth, but we need to provide the central retina with clear vision, so we put the signals to slow eye growth in the peripheral retina,” said Walline, who was not involved in the development of the newly authorized eyeglass lens.

However, some questions remain. “What exactly about that signal that the eye is specifically paying attention to, that results in the slowing of growth, that’s the part that we’re still trying to better understand,” said Berntsen, who has collaborated with Walline on various studies.

The exact aspects of a visual image that the retina processes to regulate eye growth remain complex and elusive, Berntsen said, but with better understanding can come better treatments.

“It’s really an important area of research because it affects so many people: 1 out of 3 people in the United States is nearsighted,” Walline said.

“When those people become adults, there’s a greater risk of sight-threatening complications,” he added. “We’ve got to do what we can when they are children, when myopia is developing, to try and reduce those risks far later in life.”

Myopia can cause “changes in the eye that lead to an increased risk for comorbidities down the line,” Berntsen said. “It is a disease. It’s important that we view it as that.”

Some of the complications that may come with age include an increased risk of glaucoma, which damages the optic nerve, and myopic maculopathy, or loss of central vision. There is also a higher risk of retinal detachment, in which the retina detaches from the back of the eye. All of those complications can lead to permanent vision loss, even with glasses or contact lenses.

In the future, simple eyedrops could be used to delay the onset of nearsightedness in children, which in turn can reduce those risks, Walline said.

The next frontier in nearsightedness

Walline, Berntsen and their colleagues have received $25 million in grants from the US National Institutes of Health to test whether daily drops of atropine could be effective as a way to delay the onset of myopia in children ages 6 to 11, before they even start to experience vision problems. Atropine is a drug sometimes used to dilate pupils during eye exams, and it works by relaxing muscles in the eye.

“We’re trying to delay the onset of myopia, because the later in life that you become myopic, the less myopic you are as an adult, and the less risk you have of those sight-threatening complications,” Walline said.

“It’s the first time in the United States that we’re looking at trying to treat children before they become nearsighted. We’ve always waited until after,” he said of the eye drops. “This is the new next great thing, because not only can we delay the onset, but literally, the moment they become nearsighted, they’ll already have a treatment to slow the progression of nearsightedness.”

When a child first becomes nearsighted is when their vision is changing the fastest and their eye is growing most rapidly, Berntsen said, and that would be the optimal moment to slow progression if possible.

“We know from longitudinal studies that a child’s myopia is progressing the fastest when you first see that they become nearsighted, so treat now,” he said.

Walline said that by routinely measuring a child’s vision, doctors can identify who may be approaching nearsightedness and therefore who may benefit from the eye drop treatment.

“We just measure their prescription, and when they’re close to that myopia cliff, they then have a 90% chance of becoming nearsighted by eighth grade,” Walline said.

“So we can do a good job of predicting who will become nearsighted, and then we’ll give the treatment to only them,” he said. “Hopefully we can have a bigger effect than we’ve had just by treating it after onset.”

Berntsen said that most often, children don’t even notice or realize that they may be experiencing vision changes and may be nearsighted, but that moment is the most critical for administering treatment.

“It’s a gradual change in vision. In fact, most kids don’t realize that they’re not seeing well, they just think, ‘Oh, this is how everybody sees.’ And it’s usually a vision screening where it is first noted that there is a problem,” Berntsen said.

The eyedrops could serve as another option for those children.

“It’s very helpful to have options, because there are kids who won’t want to wear glasses. There are kids that want contact lenses, and there’s some that don’t want to touch a contact lens. There’s some that don’t want any of the above, and that’s sometimes where the eye drops come in – if a kid won’t wear their glasses or contacts, even though it makes them see better,” Berntsen said. “That’s where having a range of things is really helpful from a treatment and management standpoint.”

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