Revolutionary Study Reveals Surprising Cure for Nearsightedness: Low-Dose Atropine!

The three-year study found that a daily drop in each eye of a low dose of atropine, a drug used to dilate the pupils, was better than placebo at limiting eyeglass prescription changes and inhibiting eye elongation in myopic children from 6 to 10 years. .

That elongation leads to nearsightedness, or nearsightedness, which begins in young children and continues to worsen into adolescence before leveling off in most people. In addition to requiring lifelong vision correction, nearsightedness increases the risk of retinal detachment, macular degeneration, cataracts, and glaucoma later in life, and most corrective lenses do nothing to stop the progression of the vision. myopia.

“The idea of ​​keeping the eyeballs smaller is not just to make people’s glasses thinner, it would also be to keep people’s eyeglasses from becoming visually impaired at age 70,” said study lead author Karla Zadnik, a professor and Dean of the College of Optometry at The Ohio State University.

“This is exciting work for the myopia research community, which I have been a part of for 35 years. We have talked about treatment and control for decades,” he said. “And it’s exciting to think that there could be options in the future for millions of children who we know will be nearsighted.”

Results of the CHAMP (Childhood Atropine for Myopia Progression) trial are published today (June 1, 2023) in JAMA Ophthalmology.

Approximately one in three adults worldwide is myopic, and the worldwide prevalence of myopia is projected to increase to 50% by 2050. Although a federally approved contact lens can slow the progression of myopia, there is no pharmaceuticals approved in the United States or Europe to treat myopia.

Years ago, animal studies hinted at atropine’s ability to slow eye growth, but the pure drug’s interference with near vision and concerns about pupil dilation hampered early considerations of its potential as a human therapy. for myopia. More recent research has suggested that a low dose of atropine might do the trick.

This new randomized, double-blind, phase 3 trial evaluated the safety and efficacy of two low-dose solutions, with atropine concentrations of 0.01% or 0.02%, versus placebo. Treatment for each of the 489 children aged 6 to 10 years evaluated for drug efficacy consisted of one daily drop per eye at bedtime, which minimized disruption of the blurring effects that atropine might have on the vision.

The researchers were somewhat surprised to find that the most significant improvements at all time points compared to placebo resulted from the solution containing 0.01% atropine. Although the 0.02% atropine formulation was also better at slowing the progression of myopia than placebo, the results were less consistent.

“The 0.01% story is clearer and more obvious in terms of significantly slowing down both eye growth and leading to a lower eyeglass prescription,” Zadnik said.

Including a measure of eye growth was a key component of the study because “the field is actually moving toward axial elongation, being as important or more important than spectacle prescription in terms of the most significant outcome,” he said. “If we’re trying to slow eye growth to avoid poor outcomes for people in their 80s, measuring eye growth directly is really important.”

The safety of the medications was evaluated in a larger sample of 573 participants that also included children from 3 to 16 years of age. Both low dose formulations were safe and well tolerated. The most common side effects were sensitivity to light, allergic conjunctivitis, eye irritation, dilated pupils, and blurred vision, although reports of these side effects were rare.

The CHAMP trial was the first study of low-dose atropine to include placebo controls over three years and involved a large and diverse population recruited from 26 clinical sites in North America and five countries in Europe. In a second section of the trial, the researchers are evaluating how the eyes respond when the treatment ends.

The experimental drug is made without preservatives and, if approved by the federal government as a therapy, would be distributed in single-use containers for convenience and to avoid contamination. Unlicensed low-dose atropine currently available at compounding pharmacies may contain preservatives that can cause dry eye and corneal irritation, the researchers noted.

The experimental product studied in the CHAMP trial is manufactured by Vyluma, a development-stage biopharmaceutical company in New Jersey that focuses on pharmaceutical treatments for refractive errors of the eye. A subsidiary of Nevakar Inc., Vyluma sponsored the trial, submitted a new drug application to the FDA to seek US approval, and partnered with two companies to market the product outside of the United States.

Zadnik led the study as a paid expert consultant to Vyluma. Jennifer Fogt, an assistant professor at Ohio State, also worked on the essay. Additional coauthors Erica Schulman of SUNY College of Optometry; Ian Flitcroft of the Dublin Eye Research Centre, Ireland; Louis Blumenfeld of Central Florida Ophthalmologists; and Tung Fong, Eric Lang, Houman Hemmati and Simon Chandler of Vyluma represented the CHAMP trial group investigators.