Caution: New Drug―Limited by Federal (United States) law to investigational use.
Copyright © 2020 Eyenovia, Inc. All rights reserved.
Q: What is pediatric myopia?
A: Pediatric myopia is nearsightedness that continues to worsen year after year in children due to axial elongation in the eye. This progression can result in severe myopia (also called high myopia) that may be associated with potentially serious side effects.3 This differs from the common myopia we see in adults, which generally remains stable. High myopia is a leading cause of blindness because it may result in retinal detachment, glaucoma, cataracts, choroidal neovascularization, staphyloma, and myopic macular degeneration.4
3. Duff, BL., Heiting G. What is high myopia? https://www.allaboutvision.com/conditions/myopia-faq/high-myopia.htm. Accessed December 2, 2019.
4. Holden, BA., Wilson, DA., Jong, M., et al. Myopia: a growing global problem with sight-threatening complications. Community Eye Health. 2015;28(90):35.
Q: How common is pediatric myopia?
A: In 2016, there were an estimated 30 million children with myopia in the United States, of which approximately 5 million would be considered highly myopic.1,5
1. Theophanous Christos et al. “Myopia prevalence and risk factors in children.” Clinical ophthalmology. (Auckland, N.Z) vol. 12 1581-1587. 26 Aug. 2018. doi:10.2147/OPTH/S164641. 5. Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036–1042.
Q: How myopia is currently treated?
A: There are several different treatment options currently available to eyecare professionals for correcting vision and/or reducing myopia progression in. Many options only work to correct patients’ vision, not treat myopia progression.
One treatment option are Ortho-K lenses. Ortho-K lenses are worn overnight and temporarily reshape the cornea, improving vision for the following day. These lenses have been shown to reduce myopia progression.
Another option for treatment is bifocal lenses, also known as bifocals. Bifocals are glasses with lenses that have two different prescriptions in the same lens: one for objects far away (distance vision) and the other for objects close by (near vision).
Bifocals only assist with vision correction and do not reduce myopia progression.
Multifocal contact lenses are similar to bifocal lens: they help correct both near and distance vision. They are different; however, in the number of prescriptions in each lens. Multifocal contact lenses have a range of powers, combining multiple prescriptions into each lens to help wearers focus on objects at any distance. Multifocal contact lenses also only assist with vision correction and do not reduce myopia progression.
Atropine, in the form of an eyedrop, is another treatment option. Atropine eyedrops have been shown to significantly reduce the progression of myopia.6 Clinical studies have shown that atropine actively works to stop the progression of myopia; however, there is no FDA-approved atropine treatment for myopia currently. Eyecare professionals currently prescribe compounded atropine for their patients, which can be unstable and cause some ocular side effects such as blurred vision, change in color vision, photophobia, eye pain and stinging.7
Atropine has been endorsed by the World Society of Pediatric Ophthalmology and Strabismus (WSPOS) as a myopia treatment option with an “appropriate risk-benefit ratio, with no clinically significant visual side effects balanced against a significant… reduction in myopia progression.” 8
In terms of comparative efficacy, a recent publication reviewed 41 studies of treatments intended to slow the progression of myopia (6772 children). From an analysis of these studies, the authors concluded that antimuscarinic eyedrops (atropine) was an effective treatment for slowing myopia progression in children. Multifocal contact lenses (either spectacles or contact lenses) may also confer a benefit and one lens design has recently been FDA approved for this purpose. Orthokeratology contact lenses were more effective than single vision lenses in slowing axial elongation.5
5. Walline JJ, Lindsley KB, Vedula SS, Cotter SA, Mutti DO, Ng SM, Twelker Jd. 6. Chia, Audrey, et al. “Five-Year Clinical Trial on Atropine for the Treatment of Myopia” Ophthalmology, vol. 123, no. 2, 2016, pp. 391–399., doi:10.1016/j.ophtha.2015.07.004. 7. “Atropine Sulfate (Ophthalmic Route) Side Effects.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 1 Sept. 2019, www.mayoclinic.org/drugs-supplements/atropine-sulfate-ophthalmic-route/side-effects/drg-20313091. 8. Leo, Seo Wei. “Current Approaches to Myopia Control.” Current Opinion in Ophthalmology, vol. 28, no. 3, May 2017, pp. 267–275., doi:10.1097/icu.0000000000000367. Interventions to slow progression of myopia in children. Cochrane Database of Systematic Reviews 2020, Issue 1. Art. NO.CD004916. DOI: 10.1002/14651858.CD004916.pub4
Q: Are new treatments being explored for myopia?
A: A number of pharmaceutical companies are developing new atropine formulations that may ultimately pass FDA approval.
Eyenovia is one of these companies, but what separates us from our competitors is our microdosing technology. ECPs who are hesitant to prescribe atropine due to the drug’s known side effects will soon have a safer and effective atropine treatment option. The ocular side effects from atropine could potentially be minimized by lowering the volume of the dose. Eyenovia’s Optejet® dispenser will allow patients to microdose atropine at approximately 1/5 the dose size of an eyedrop using an easy-to-use horizontally distilling dispenser.
Eyenovia’s NDA-enabling Phase III study, CHAPERONE, began in 2019 aims to prove the benefits of microdosing atropine in children suffering from progressive myopia. The 3-year study is set to complete in 2023, making Eyenovia one of the first to US market with an FDA approved treatment for myopia using atropine.
Not only is the Optejet® designed to comfortably deliver a much lower dose of atropine than the traditional eyedropper, it also has the capability to help with patient compliance and adherence to therapy. The dispenser base is equipped with a Bluetooth chip that can be paired with a smartphone app. The app could be used to track when the medication is dispensed and remind the patient to use the Optejet®