The company suggests the CE mark approval will provide greater confidence for parents
CooperVision Specialty EyeCare’s orthokeratology myopia control lenses, Paragon CRT and Paragon CRT Dual Axis, have received Conformitè Europëenne (CE) markings for slowing the progression of myopia.
The CE mark represents the highest approval range for ortho-k lenses in the region, as well as the first ortho-k myopia control option approved by the European Union for patients with myopia over 4.00 dioptres, the company said.
Both the contact lens designs are approved in 32 European markets for myopia control indications for children and young adults with up to 6.00 dioptres of myopia and up to 1.75 diopters of astigmatism.
Leah Johnson, global professional services director for Paragon Vision Sciences, commented: “We are enthusiastic about bringing European ECPs additional evidence-based, approved overnight wear options for slowing the progression of myopia.”
“With the CE mark achievement, ECPs can create even more confidence in parents that Paragon CRT is safe and effective for both myopia correction and control, changing children’s lives immediately and well into the future,” Ms Johnson continued.
She highlighted that eye care professionals retain the choice of selecting the best fitting philosophy, software and disinfection solution for each child.
Paragon CRT lenses were shown to reduce axial length growth by 56% in a two-year study, the company pointed out.
Commenting on the announcement, Dr. Juan Carlos Aragón, president, CooperVision Specialty EyeCare, called the CE mark status “another major milestone in CooperVision’s commitment to advancing myopia management technologies and practice.”
Dr Aragón added that the company is investing in its myopia management portfolio, partnerships with practitioners and in “the science required to grow the category.”
The World Health Organization has warned that myopia is increasing globally “at an alarming rate, with significant increases in the risks for vision impairment from pathologic conditions associated with high myopia.”
