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What Is Pediatric Myopia?
Myopia, or nearsightedness, is a common refractive anomaly that often begins between the ages of six and 14 and progresses over several years before stabilizing and lasting through adulthood. With myopia, the eye is longer than normal (axial elongation) from front to back, or the cornea is too steeply curved, which causes light to focus in front of the retina instead of directly on it.1,2 Those with myopia have difficulty seeing distant objects, but near objects remain clear. Myopia is a condition that may lead to higher rates of blindness and serious eye complications later in life.
Myopia is the leading cause of preventable blindness worldwide.3 If current trends continue, it is estimated that by 2050 there will be approximately 5 billion people with myopia (50% of the world’s population).4 Higher levels of myopia significantly increase a child’s risk for serious blinding eye disease to occur in their lifetime, such as myopic maculopathy, posterior staphyloma, retinal detachment, cataract, and glaucoma.5
Interventions to slow the progression of myopia include spectacles, contact lenses or behavioral modifications.5 A common treatment for myopia are various contact lens options, but safety remains a concern because the risk of sight-threatening microbial keratitis (bacterial infection of the cornea) and the possibility of regression after discontinuation of lens wear.4 Spectacles are another treatment option for children who are unable or prefer not to wear contact lenses. Behavioral recommendations for myopia patients include spending more time outdoors, limiting large amounts of time spent on screen time or reading up close, and increased exposure to sunlight.6
Given the profound impact myopia has on an individual’s long-term health and that it is an incredibly widespread condition, additional interventions are needed to help mitigate the prevalence and severity of this condition.2
The visual dysfunction and cost of managing myopia-related complications have become a heavy burden on patients and society at large. To reduce myopia progression, low-concentration atropine eye drops are a promising therapy.7
Atropine for myopia addresses the anatomic changes (i.e., longer ocular axial length) associated with myopia progression, which cannot be easily achieved with spectacles or contact lenses.8
NVK002 is an investigational, preservative-free, low-dose atropine eye drop, using Vyluma’s proprietary technology to address stability, tolerability, and safety. The CHAMP (Childhood Atropine for Myopia Progression) study includes children ages three to 17 and administration is a single drop to both eyes, nightly. The CHAMP study is currently testing two concentrations in the United States and Europe. The NDA was accepted in Q2 of 2023.