The heterogeneity of compounded atropine production and prescription practices for myopia treatment in the United States, as recently reported by Richdale et al.,1 emphasizes the potential risks of seeking off-label pharmaceutical myopia control. Like the United States, compounded off-label atropine eye drops are commonly prescribed for myopia control in Australia, and the risks identified by Richdale et al. remain relevant. Commercially available standardized treatments produced in sterile environments using regulated formulations may allay concerns such as infection, product stability, and quality1 associated with unstandardized alternatives, ensuring the safety and efficacy of long-term treatment. The Therapeutic Goods Administration in Australia recently approved Eikance eye drops (0.01% atropine sulfate monohydrate; Aspen Pharmacare Australia Pty Ltd) as a myopia control treatment for children 4 to 14 years of age with annual progression of one or more diopters.2 Eikance 0.01% retails at a comparable price with compounded, off-label atropine eye drops (approximately 28USD) and is not subsidized by the Australian Government. Given overlapping geographical latitude and increasing diversification of populations in both Australia and the United States, we use data from Australian pediatric and young adult cohorts to evaluate Eikance 0.01% therapeutic indications, which may help inform the development and introduction of standardized, uniform guidelines for atropine prescription and commercially available formulations in the United States.
Currently, there is a paucity of data to support the continued use of treatment with solutions such as Eikance 0.01% after 14 years of age.2 Nonetheless, the benefits of myopia control may extend to older individuals. Here, we demonstrate that myopia development and progression is common beyond 14 years. The incidence of self-reported or parent-reported myopia within the Gen2 cohort of the Raine Study was evaluated at 14, 17, and 20 years of age using prospective questionnaires. This analysis abided by the tenets of the Declaration of Helsinki and was approved by the University of Western Australia's Human Research Ethics Committee, and participants provided informed consent. Incidence of self-reported myopia was 9.5% between 14 and 17 years and 8.4% between 17 and 20 years. Given the high myopia incidence beyond 14 years, we may similarly expect myopia progression to remain high in late adolescence.
As previously reported in the same cohort,3 an incidence of 14% was observed between 20 and 28 years, based on cycloplegic refraction, with 2.7% progressing up to 0.25D each year, and 37.8% experiencing a 0.5D myopic shift over 8 years, including 0.7% progressing to high myopia. Although yearly progression in this cohort is smaller than typically observed in younger children, these findings suggest that myopia control may be beneficial to those beyond mid-adolescence. Given the lack of evidence of myopia control efficacy in older adolescents and young adults, this is worthy of investigation in future clinical trials.
Another important step in standardizing low-concentration atropine eyedrops for myopia control is to establish treatment guidelines based on patient's age, ancestry, and risk of myopia progression. Our recently published data from the Western Australia Atropine for the Treatment of Myopia (WA-ATOM) study4 demonstrates that 0.01% atropine has limited myopia control effects in children of East or South Asian descent, although the study was not powered for subgroup analysis based on ancestry differences.4 Similar studies have demonstrated that 0.01% atropine does not slow axial elongation,5 suggesting that children of Asian descent could benefit from higher atropine concentrations. The approval of Eikance 0.01% may be redundant for children of Asian descent living in Australia, thus a considerable portion of these individuals will continue to rely on compounded atropine formulations. Prospective revisions of Eikance 0.01% indications may consider the addition of varied treatment concentrations, pending data to support their safety and efficacy, to ensure equal opportunities to access appropriately calibrated treatment. Conversely, children who could benefit from low-concentration treatment are likely to be excluded by other criteria. For example, only 46.3% of our WA-ATOM4 study participants met all Eikance 0.01% indications, with 21% excluded based on the age cut-off, despite 51.6% of these children exhibiting myopia progression aligned with Eikance 0.01% indications.
The approval of Eikance 0.01% is a major development for myopia control in Australia. Yet, treatment indications may be excessively restrictive, excluding populations that could benefit and potentially making treatment with 0.01% concentrations redundant for children of Asian descent. Eikance 0.01% utilization in the Australian context should be monitored moving forward, as this may inform the expansion of current age and treatment concentration therapeutic indications in the future. Similarly, in countries such as the United States, the availability of standardized, commercially available atropine eyedrops of various concentrations may be beneficial as the world works to curb the myopia epidemic.
The authors acknowledge the Raine Study participants and their families for their ongoing participation in the study, as well as the Raine Study team for study co-ordination and data collection. The authors also thank the NHMRC for their long-term contribution to funding the study over the last 30 years.
1. Richdale K, Tomiyama ES, Novack GD, et al. Compounding of low concentration atropine for myopia control. Eye & Contact Lens 2022;48:489–492.
2. Therapeutic Goods Administration (TGA) Australian Register of Therapeutic Goods (ARTG). EIKANCE 0.01% atropine sulfate monohydrate 100 microgram/1mL eye drops solution packed in single-dose ampoules (331960). Australian product information. (Eikance 0.01% eye drops (atropine sulfate monohydrate) sterile ophthalmic solution). Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-02125-1&d=20221227172310101
. Accessed December 27, 2022.
3. Lee SS-Y, Lingham G, Sanfilippo PG, et al. Incidence and progression of myopia in early adulthood. JAMA Ophthalmol 2022;140:162–169.
4. Lee SS-Y, Lingham G, Blaszkowska M, et al. Low-concentration atropine eyedrops for myopia control in a multi-racial cohort of Australian children: A randomised clinical trial. Clin Exp Ophthalmol 2022;50:1000–1012.
5. Yam JC, Jiang Y, Tang SM, et al. Low-concentration atropine for myopia progression (LAMP) study: A randomized, double-blinded, placebo-controlled trial of 0.05%, 0.025% and 0.01% atropine eye drops in myopia control. Ophthalmology 2019;126:113–124.