Although the use of atropine is not necessarily novel in the myopia management world, the fact that practitioners may soon have an FDA approved formulation of atropine is new and exciting.
Atropine has been used off-label for decades as a safe and effective monotherapy option, or as a counterpart in combination therapy along with orthokeratology or soft multi-focal contact lenses.
In addition to not being commercially available, one of the major barriers to successful implementation into everyday practice is that it is not currently FDA approved. Parents and practitioners alike often shy away from this pharmaceutical option due to the lack of extensive evidence on safety and efficacy.
Guiding our path now are the findings from clinical trials like Low-Concentration Atropine for Myopia Progression (LAMP) and Atropine for the Treatment of childhood Myopia (ATOM1/ATOM2). Despite a wealth of information coming from these studies, there is currently no solid or conclusive evidence on the ideal concentration of atropine.
The Childhood Atropine for Myopia Progression (CHAMP) trial is the most well-done trial to date. It is a three-arm, randomized, double-masked, placebo-controlled clinical trial sponsored by Vyluma.1,2 The formulations being tested are shelf-stable at room temperature, preservative-free, and dosed once per day at night.
With sites both in the United States and Europe, the trial included children aged 3-17 from a variety of ethnic backgrounds with myopia from -0.50 D.S. up to -6.00D D.S. and no more than -1.50 D of astigmatism.
Currently, the trial is in phase 3 and has thus far determined that low dose formulations of 0.01% and 0.02% are both safe with very few adverse events. In addition, 0.01% was efficacious in slowing myopia progression as evidenced by spherical equivalent refractive error and axial length measurements when compared to the placebo after 3 years.
If approved, the drop would be the first and only pharmaceutical agent for the treatment of childhood myopia progression.
Although we are one step closer to adding an additional FDA approved option to our myopia management repertoire, there are still many unanswered questions. However, this addition will, undoubtedly, allow practitioners to manage more patients but especially those who have limited options due to age, ability, and financial concerns.