CHAMPioning Myopia Management

Researchers from The Ohio State University College of Optometry, along with colleagues from the study sponsor Vylum, (and collaborators across the United States and Europe) have published data from the Childhood Atropine for Myopia Progression (CHAMP) study (1) – the first placebo-controlled, randomized, three-year phase III clinical trial in a US/Europe-based sample of children.

“I’ve been engaged in myopia research for 35 years. This is exciting work for the myopia research community and eye care practitioners alike. We’ve talked about treatment and control for decades. It’s exciting to think there could be options in the future for millions of children we know are going to be myopic,” said lead study author Karla Zadnik, Professor and Dean of the College of Optometry at The Ohio State University, in a press release (2).

The team sought to establish the safety and efficacy of two low-dose solutions (0.01 percent and 0.02 percent) versus placebo – both manufactured by trial sponsor Vyluma (New Jersey, USA). Each of the 489 children (aged 6–10 years) received a nightly application of one drop per eye. The dosing strategy and the low concentration help to minimize the potential visual disturbances caused by atropine-induced mydriasis and cycloplegia.

The researchers discovered that the 0.01 percent atropine formulation delivered the most significant improvements at all time points compared with placebo. Though the 0.02 percent atropine formulation did slow eye growth more than the placebo, the results were less consistent.

The researchers also noted in the press release that off-label, low-dose atropine are currently obtained from compounding pharmacies; however, there are limitations to those formulations. Vyluma’s formulation is preservative free and packaged in single ampules intended for daily application.