CooperVision, a contact lens developer based in San Ramon, California, recently received FDA approval for its MiSight 1 day contact lens. The lens is the first to slow the progression of myopia when worn by children aged 8-12 years old.
Myopia is very common, but it doesn’t just affect the way someone sees objects at a distance, and can trigger other conditions such as detached retina and cataracts. The condition typically develops during childhood, and can makes things like seeing the blackboard at school difficult for kids.
Myopia occurs when the eyeball grows too long, meaning that light rays are focused at a point in front of the retina, rather than on it. This makes things that are farther away appear blurry, and requires corrective lenses. The condition can progress during childhood, requiring lenses with a stronger corrective ability, and the progression of myopia has been linked to an increased risk of sight-threatening conditions such as glaucoma, retinal detachment. and myopic maculopathy.
To date, glasses and contact lenses used to treat myopia merely offer a correction for the impaired vision associated with the condition, but do not slow its progression. To address this limitation, CooperVision has introduced the MiSight 1 day. The lens contains concentric rings, some that correct the refractive error and which provide clear vision, and some that help to focus the light entering the eye in front of the retina, which counter-intuitively slows down the progression of myopia.
In a study involving 144 children, the MiSight 1 day lenses were shown to slow the progression of myopia over the space of three years, potentially sparing the kids related complications when they are older.
Medgadget had the opportunity to talk to Michele Andrews, OD, senior director of professional and academic affairs for North America at CooperVision about the MiSight 1 day lenses.
Conn Hastings, Medgadget: Please give us an overview of the problems myopia can cause, both in childhood and in later life. Is myopia becoming more prevalent?
Michele Andrews, CooperVision: A child with uncorrected myopia, or nearsightedness, will experienced blurred vision when trying to see something at a distance. What that means for the child is that everyday activities may become more difficult—they may struggle to see the board at school or to participate in activities such as sports, movies, or other activities that require clear distance vision with their friends or families.
Later in life, higher levels of myopia are linked with an increased risk of sight-threatening issues such as retinal detachment, cataracts, and glaucoma.
Our vision is to help eye care practitioners move beyond just correcting the refractive error and make slowing the progression of myopia the standard of care for nearsighted children.
Nearly half of children aged 5–19 in the U.S. are myopic, according to a study published in August 2018—and it is projected to become even more prevalent. Another study estimates that 5 billion people will be myopic by 2050. This growing prevalence adds an urgency to our work and makes education for parents a major component.
Medgadget: How do the MiSight 1 day lenses work to slow the progression of myopia?
Michele Andrews: When someone is myopic, it means that their eye has elongated, causing light rays to focus at a point in front of the retina instead of directly on the surface—resulting in blurred vision. To slow the progression of myopia, we need to slow that elongation.
To do that, MiSight 1 day contact lenses use what we call ActivControl Technology—alternating zones of vision correction and treatment zones in the form of concentric circles.
Picture a bullseye. Two of the alternating rings correct vision as a traditional contact lens would. The other two rings are treatment zones that channel light rays in a way that creates “myopic defocus” that has been shown to slow the elongated growth of the eye, slowing the progression of myopia.
MiSight 1 day is FDA-approved for slowing the progression of myopia in children, who at initiation of treatment are 8-12 years of age.
In the U.S., MiSight 1 day will be prescribed along with our comprehensive Brilliant Futures Myopia Management Program to provide additional education and support for parents and children to encourage treatment compliance and ensure the best outcomes.
Medgadget: Are these therapeutic benefits permanent, or is it necessary to continue to wear the lenses beyond childhood to prevent myopia progression?
Michele Andrews: We’re currently exploring that very question. We’re conducting a cessation study that will track the vision of two groups of children no longer wearing MiSight 1 day who have previously worn the treatment for three years and six years.
This ongoing pediatric myopia management study has been one of the most exciting parts of our journey with MiSight 1 day and the Brilliant Futures Myopia Management Program. Running for six years and counting, it is the world’s longest-running clinical trial of pediatric contact lens wear.
Medgadget: Please give us an overview of the results of the MiSight 1 day clinical studies conducted so far.
Michele Andrews: Our landmark clinical study of pediatric myopia management has unfolded in multiple parts:
Part one of the study—the data reviewed by the FDA—quantified three-year effectiveness of MiSight 1 day compared with a traditional single vision 1-day lens in slowing the rate of progression of pediatric myopia. We saw a significant difference between children wearing MiSight 1 day and those in the control group.
Part two of the study involved fitting children from the original control group with MiSight 1 day, so that all participants were being treated for myopia. The latest data reveals that the myopia progression rates of the original control group reduced dramatically and now match the rates of the children who have been wearing MiSight 1 day for the entire duration of the study.
Medgadget: CooperVision has developed an app to accompany the lenses. What features does it offer?
Michele Andrews: As part of the Brilliant Futures Myopia Management Program in the U.S., the mobile app will give parents and children easy access to myopia management information, lens handling instructions and videos, appointment scheduling and reminders, product ordering and more. The program is designed to keep patients engaged with their eye care practice and the program of care to ensure the best possible results.
Through Harris Poll survey results we released at the end of last year, we learned that only a third of parents know what myopia is and how it can affect their children’s future eyesight. Through the app and other elements of Brilliant Futures, we’re giving them the tools they need to be informed and successful.
Medgadget: How do you see this type of technology developing in the future? Do you have any plans to develop other disease-modifying contact lenses?
Michele Andrews: Looking ahead, the results from our clinical study as well as other initiatives have given us valuable insights as we consider pathways in myopia management. We also know that researchers around the world are exploring other technologies and treatments. Because our ultimate goal is to see slowing myopia progression become the standard of care, we’re thrilled to be at the forefront growing discussion and look forward to seeing what the future will hold.
As a company, CooperVision has always had a focus on solving difficult vision challenges and our approach to myopia management will follow in that same tradition.
Product page: MiSight 1 day contact lens…