Pivotal International Seven-Year MiSight® 1 day Contact Lens Study Indicates No Myopia Control Rebound in Children

Data Shows Eye Growth Slowed for All Tested Ages with
Highly-Desired Proportional Treatment Effects

 

SOUTHAMPTON, UNITED KINGDOM, 10 NOV 2021.—CooperVision, a world leader in myopia control and management for children, today announced new seven-year findings from its pivotal MiSight^® 1 day contact lens clinical trial. Twelve months following treatment cessation, mean axial elongation data indicate no evidence of rebound effect, meaning the myopia control gains are retained.[i]^,[ii]†

 

The study is the world’s longest continuous running soft contact lens clinical trial for myopia control. CooperVision previously reported that MiSight^® 1 day showed sustained slowing of myopia progression across multiple years of treatment. This was observed in a cohort that wore MiSight^® 1 day for the study’s first six years as well as the original control group who were switched into MiSight^® 1 day for three years.[iii]

 

“Our unparalleled research clearly illustrates the tremendous potential of MiSight^® 1 day for children of different ages and with different levels of myopia, regardless of when they start treatment.³ With these results, eye care professionals should be even more confident in prescribing MiSight^® 1 day,” said Paul Chamberlain, BSc (Hons), MCOptom, the study’s principal investigator and CooperVision Director of Research Programs.

 

The latest data analysis goes even deeper to illustrate that MiSight^® 1 day offers a highly-desired proportional myopia control treatment effect. Abnormal axial length growth slowed by an average of approximately 50% with all tested ages (8-17).[iv] Because younger children’s myopia progresses faster than in older children,[v] introducing MiSight^® 1 day at the earliest opportunity may offer the maximum cumulative benefit over time.⁴

 

In the study’s seventh year, participants were transitioned from MiSight^® 1 day to a single vision contact lens to evaluate if treatment gains would be retained. Myopic progression then occurred only at anticipated ‘age-normal’ levels—not at an accelerated “catch up” rate that would offset prior myopia control gains.^1,2 This indicates no rebound effect.

 

“We saw these children grow into young adults during their seven years in the study. It is personally as well as professionally fulfilling to know that the benefits of treatment are retained. As MiSight^® 1 day becomes more widely available and as myopia management becomes the standard of care, I hope other eye care professionals will experience that same joy,” said study investigator Nicola Logan, PhD, Professor of Optometry and Physiological Optics, Aston University.

 

MiSight^® 1 day contact lenses are specifically designed for myopia control and are FDA* approved to slow the progression of myopia in children aged 8-12 at the initiation of treatment.^‡ In August, MiSight^® 1 day received approval from the Chinese National Medical Products Administration (NMPA) to become the first indicated product of any type that may slow the progression of axial length.^§  MiSight^® 1 day contact lenses are already being successfully worn by thousands of myopic children in the UK and across the world.

 

 

CooperVision researchers shared their findings in November at this year’s American Academy of Optometry Annual Meeting, the globally-renowned scientific and clinical conference. For more information, visit CooperVision.com.

 

# # #

 

Disclaimer: The stability of the myopia reduction effect 1-year post-treatment is being further evaluated in a post-approval study in the U.S. as a condition of FDA approval of MiSight^® 1 day.

 

^† Preliminary international study data shows that, on average, for children that discontinued treatment at age 14-19 following 3 or 6 years of MiSight^® 1 day wear, the eye growth reverted to age-expected average myopic progression rates.

 

* U.S. Indications for Use: MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal.

 

^‡ Compared to a single vision 1 day lens over a 3-year period. Fitted at 8-12 years of age at initiation of treatment.

 

^§ China Indications for Use: MiSight^® is indicated for the correction of myopia for patients with non-diseased phakic eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 D to -4.00 D with ≤ 0.75 diopters of astigmatism. Its dual focal design with alternative multiple rings allows part of the light passing through the optical zone to focus in front of the retina, forming myopic defocus and is expected to slow axial length progression of patients. Fitting and evaluation of the product should be in medical institutions by ophthalmologists with an intermediate title or above, including regular evaluations. It must be used in strict accordance with the IFU requirements.

 

About CooperVision

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of contact lenses. The company produces a full array of daily disposable, two-week and monthly soft contact lenses that feature advanced materials and optics, and premium rigid gas permeable lenses for orthokeratology and scleral designs. CooperVision has a strong heritage of addressing the toughest vision challenges such as astigmatism, presbyopia, childhood myopia, and highly irregular corneas; and offers the most complete portfolio of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

 

About CooperCompanies

CooperCompanies ("Cooper") is a global medical device company publicly traded on the NYSE (NYSE:COO). Cooper operates through two business units, CooperVision and CooperSurgical. CooperVision brings a refreshing perspective on vision care with a commitment to developing a wide range of high-quality products for contact lens wearers and providing focused practitioner support. CooperSurgical is committed to advancing the health of women, babies and families with its diversified portfolio of products and services focusing on medical devices and fertility & genomics. Headquartered in San Ramon, Calif., Cooper has a workforce of more than 12,000 with products sold in over 100 countries. For more information, please visit www.coopercos.com. 

 

Media Contact

Tom Chapman, Five by Five

tom.chapman@fivebyfiveglobal.com 

023 8082 8525