Eye drops slow nearsightedness progression in kids: study

The first drug therapy to reduce the onset of myopia in children may be on the horizon, according to recent clinical research findings. A three-year study found that one daily drop in each eye of a low dose of atropine, a drug used to dilate the pupils, was effective in limiting changes in eyeglass prescriptions and increasing nearsightedness between the ages of 6 and 10. was superior to placebo in preventing eye enlargement in sighted children. ,

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

“The idea of ​​keeping the eyes smaller isn’t just that people’s glasses are thinner — it’s also that they won’t suffer visual loss in their 70s,” said lead study author Carla Jadnik, professor and dean of the College of Optometry. ” at The Ohio State University.

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“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,” she said. “And it’s exciting to think that there may be options in the future for the millions of children who we know are going to be myopic.”

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

Nearly one in three adults worldwide is nearsighted, and the global prevalence of myopia is predicted to increase to 50 percent by 2050. myopia.

Animal studies hinted at atropine’s ability to slow eye growth years ago, but the full-strength drug’s interference with nearsightedness and concerns about pupil dilation have limited its potential as a human treatment for myopia. Initial thoughts hindered. Recent research has suggested that low doses of atropine may be just the ticket.

This new double-masked, randomized phase 3 trial assessed the safety and effectiveness of two low-dose solutions containing atropine concentrations of either .01 percent or .02 percent versus placebo. Treatment for each of the 489 children ages 6 to 10 who were evaluated for the drug’s effectiveness consisted of one daily drop per eye at bedtime, minimizing the disruption of any blurring effects that atropine may have on vision. Is.

The researchers were a little surprised to find that the solution containing .01 percent atropine resulted in the most significant improvement at all time points compared to placebo. Although the .02 percent atropine formulation was also better at slowing the progression of myopia than placebo, the results were less consistent.

“The story of .01 percent significantly slowing eye growth as well as resulting in fewer eyeglass prescriptions is clearer and more pronounced,” Jadnik said.

Including a measure of eye growth was a key component of the study because “the field really moving toward axial elongation is as important, or more important, than eyeglass prescription in terms of the most meaningful outcome,” she said. . “If we’re trying to slow eye growth to prevent worse outcomes for people in their 80s, it’s really important to measure eye growth directly.”

The safety of the drugs was assessed in a larger sample of 573 participants, including children under the age of 3 and up to the age of 16. Both low-dose formulations were found to be safe and well-tolerated. The most common side effects were sensitivity to light, allergic conjunctivitis, eye irritation, dilated pupils, and blurred vision, although these side effects were rarely reported.

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

The experimental drug is made without preservatives and, if federally approved as a therapy, would be distributed in single-use packaging for convenience and to prevent contamination. The researchers noted that the off-label low-dose atropine that can currently be obtained at compounding pharmacies may contain preservatives that can cause dry eye and corneal irritation.

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

Zadnik led the study as a paid expert advisor to Vyluma. Jennifer Phogat, assistant professor at Ohio State, also worked on the test. Additional co-authors Erica Shulman of the SUNY College of Optometry; Ian Flitcroft of the Center for Eye Research in Dublin, Ireland; Louis Blumenfeld of Eye Physicians of Central Florida; and Tung Fong, Eric Lang, Homan Hemmati and Simon Chandler of Wylluma, representing the CHAMP trial group investigators.