Why Myopia?


In 2017 the World Health Organization (WHO), American Academy of Ophthalmology (AAO) and the World Society of Paediatric Ophthalmology and Strabismus (WSPOS) issued public statements identifying myopia as a massive global health problem and that myopia represents a major unmet medical need with no approved drugs to treat the disease. Since then, additional organizations have taken heed and issued statements of their own including the United Nations and the European Society of Ophthalmology. Most significantly, in 2019 the AAO created a Global Myopia Task Force partnering with the American Academy of Family Physicians (AAFP), the American Academy of Optometry (also the AAO), and the American Academy of Pediatricians (AAP). The task force released a mission statement in late 2020 stating their goal of addressing the myopia epidemic by focusing efforts on myopia early screening and treatment, as well as education. The task force highlighted low dose atropine as “the most reasonable approach to myopia control”.

Myopia the Disease

Myopia used to be considered a benign refractive disorder but is now widely recognized as a disease with significant ocular comorbidities that can occur later in life. Myopia tends to progress the most in children between the ages 5 and 15. While the precise mechanism responsible for causing myopia is unknown, the disease is believed to involve both genetic and environmental components. Near vision activities using phones, ipads, and computers have only exacerbated the incidence and progression of myopia.

Treating Myopia

A safe and effective pharmacologic treatment for myopia has evaded researchers until a groundbreaking study was published in the early 2010’s. Commercially available atropine (1.0% and 0.5%) has been tested and been shown to be effective in treating the progression of myopia, however these high doses also have a very high incidence of adverse events that typically result in discontinuation of treatment. As a result, progressively lower doses of atropine have been tested to optimize the safety versus efficacy. Chia et al., 2012 found that 0.01% atropine given once a day retains virtually the same efficacy as 1% atropine, but with a marked reduction in side effects. This result was more widely recognized in 2017 with consensus statements by both the AAO and the WSPOS acknowledging low-dose atropine as the preferred treatment paradigm with a favorable risk-benefit ratio to minimize myopic progression. As no formulations of 0.01% atropine are approved anywhere in the world, physicians have to write off label prescriptions for compounding pharmacies to supply their patients.
Unfortunately, compounded (0.01%) atropine is pharmacologically unstable, and can result in significant degradation after even 3 months at room temperature. Most compounded low dose atropine formulations obtained from compounding pharmacies have short term (~30 day) shelf life. The nearer to physiologic pH (~7.4) and the lower the atropine concentration, the higher the rate of degradation. Unstable drug product poses numerous concerns for all stakeholders involved including regulatory agencies, health care professionals, and most importantly patients.
Sydnexis has uniquely solved this problem with a novel, stable, and comfortable topical eyedrop formulation designed to be administered once daily at bedtime.