CooperCompanies Announces CooperVision Has Received FDA Approval of MiSight® for the Treatment of Myopia in Children
Becomes the First and Only FDA Approved Contact Lens of its Kind in the U.S.
SAN RAMON, Calif., Nov. 18, 2019 (GLOBE NEWSWIRE) -- CooperCompanies (NYSE: COO), announced today that CooperVision has received U.S. Food and Drug Administration (FDA) approval of its MiSight® 1 day contact lens1, indicated to slow the progression of myopia (nearsightedness or short-sightedness) when initially prescribed for children 8-12 years old. MiSight® 1 day has been scientifically proven to reduce myopic progression by up to 59%2. This is the first FDA approved myopia management contact lens and is expected to be available in the U.S. beginning in March of 2020.
“MiSight is a revolutionary product that can make a meaningful difference in the lives of children needing visual correction,” said President and CEO Al White. “Today’s approval is a big step forward for the ophthalmic industry as eye care professionals finally have an approved treatment for slowing the progression of myopia rather than just providing glasses or contact lenses to mask the condition. The increased incidence of myopia is a global epidemic so it’s exciting to see an FDA approved product which can now become the standard-of-care within the ophthalmic industry to treat this crisis.”
Additional information may be found on CooperVision.com and in the CooperVision MiSight press release.
1 MiSight™ (omafilcon A) daily wear single use Soft Contact Lenses 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.
2 When compared to the children in the control group wearing a single vision 1-day contact lens.
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 .
Forward-Looking Statements
This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Statements relating to guidance, plans, prospects, goals, strategies, future actions, events or performance and other statements of which are other than statements of historical fact, and all statements regarding MiSight and its future availability, acquisitions including the acquired companies’ financial position, market position, product development and business strategy, expected cost synergies, expected timing and benefits of the transaction, difficulties in integrating entities or operations, as well as estimates of our and the acquired entities’ future expenses, sales and diluted earnings per share are forward-looking. In addition, all statements regarding anticipated growth in our revenue, anticipated effects of any product recalls, anticipated market conditions, planned product launches or approvals and expected results of operations and integration of any acquisition are forward-looking. To identify these statements, look for words like "believes," "outlook," "probable," "expects," "may," "will," "should," "could," "seeks," "intends," "plans," "estimates" or "anticipates" and similar words or phrases. Forward-looking statements necessarily depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Events that could cause our actual results and actions of the Company to differ from those described in forward-looking statements are described in our SEC filings, including Cooper’s Form 10-K, all of which are available on our website at coopercos.com.
Contact:
Kim Duncan
Vice President, Investor Relations and Administration
925-460-3663
