FDA News

FDA approves contact lens to slow myopia progression

Michele Andrews

The FDA approved CooperVision’s MiSight 1 day contact lens to slow the progression of myopia in children 8 to 12 years old.

This daily wear, single use contact lens made of omafilcon A is indicated for children with a refraction of -0.75 D to -4.00 D with no more than -0.75 D of astigmatism, a company representative told Primary Care Optometry News.

MiSight is the first FDA-approved contact lens proven to slow the progression of myopia, the company said in a press release. It is already being worn by children in Canada, the U.K., Spain and Australia.

“This lens represents something practitioners have been waiting for, and ultimately we’ll see that parents and children have been waiting for: a product that has FDA approval with strong clinical evidence that is easy to use,” Michele Andrews, OD, senior director of professional and academic affairs, North America, CooperVision, told PCON in an interview. “It will change the way everyone looks at myopia management.”

She said the approval is important for the entire industry.

“It provides an opportunity for doctors and patients – or parents – who may have been hesitant to consider other options,” Andrews said. “They now have something they can look to for approaching the myopia epidemic in a different way.”

The MiSight 1 day will launch in the U.S. as part of a CooperVision myopia management initiative beginning in March 2020, the company said in the release.

Andrews said she anticipates that practitioners can begin prescribing the lens in the spring.

“Optometry needs to own myopia control,” Andrews said. “This is a significant opportunity for us and for all the kids who are in this space.”

She said the company will “continue to talk about myopia, continue to help educate eye care providers as well as parents about the epidemic and, now that we can do this, we will share more about the lens itself.”

PCON previously reported 4-year clinical study results indicating that the MiSight contact lens slowed myopia progression by 59% as measured by mean cycloplegic spherical equivalent and by 52% as measured by mean axial elongation of the eye when compared to the children in the control group wearing a single vision daily disposable contact lens.

Complying with the wearing schedule is important for positive outcomes, a company representative told PCON. During the study, children were required to wear the MiSight lens a minimum of 6 days a week and 10 hours a day to provide maximum treatment time. On average, the children wore them more than 12 hours a day, and most wore them every day.

Andrews told PCON that the children in CooperVision’s clinical study will remain enrolled, “and we’ll continue to evaluate them and report out as they progress through the protocol, so there will be more clinical data to come.” – by Nancy Hemphill, ELS, FAAO


Disclosure: Andrews is employed by CooperVision.

Michele Andrews

The FDA approved CooperVision’s MiSight 1 day contact lens to slow the progression of myopia in children 8 to 12 years old.

This daily wear, single use contact lens made of omafilcon A is indicated for children with a refraction of -0.75 D to -4.00 D with no more than -0.75 D of astigmatism, a company representative told Primary Care Optometry News.

MiSight is the first FDA-approved contact lens proven to slow the progression of myopia, the company said in a press release. It is already being worn by children in Canada, the U.K., Spain and Australia.

“This lens represents something practitioners have been waiting for, and ultimately we’ll see that parents and children have been waiting for: a product that has FDA approval with strong clinical evidence that is easy to use,” Michele Andrews, OD, senior director of professional and academic affairs, North America, CooperVision, told PCON in an interview. “It will change the way everyone looks at myopia management.”

She said the approval is important for the entire industry.

“It provides an opportunity for doctors and patients – or parents – who may have been hesitant to consider other options,” Andrews said. “They now have something they can look to for approaching the myopia epidemic in a different way.”

The MiSight 1 day will launch in the U.S. as part of a CooperVision myopia management initiative beginning in March 2020, the company said in the release.

Andrews said she anticipates that practitioners can begin prescribing the lens in the spring.

“Optometry needs to own myopia control,” Andrews said. “This is a significant opportunity for us and for all the kids who are in this space.”

She said the company will “continue to talk about myopia, continue to help educate eye care providers as well as parents about the epidemic and, now that we can do this, we will share more about the lens itself.”

PCON previously reported 4-year clinical study results indicating that the MiSight contact lens slowed myopia progression by 59% as measured by mean cycloplegic spherical equivalent and by 52% as measured by mean axial elongation of the eye when compared to the children in the control group wearing a single vision daily disposable contact lens.

Complying with the wearing schedule is important for positive outcomes, a company representative told PCON. During the study, children were required to wear the MiSight lens a minimum of 6 days a week and 10 hours a day to provide maximum treatment time. On average, the children wore them more than 12 hours a day, and most wore them every day.

Andrews told PCON that the children in CooperVision’s clinical study will remain enrolled, “and we’ll continue to evaluate them and report out as they progress through the protocol, so there will be more clinical data to come.” – by Nancy Hemphill, ELS, FAAO


Disclosure: Andrews is employed by CooperVision.