Johnson & Johnson Vision gains FDA approval for overnight myopia management lens

Johnson & Johnson Vision has received US Food and Drug Administration (FDA) approval for its myopia management product, Acuvue Abiliti Overnight Therapeutic Lenses.

The company said this is the “first and only” FDA approved orthokeratology (ortho-k) contact lens for myopia management.

The lenses will also be available in a design for astigmatism.

It is expected that the lenses will be released in the US by the end of 2021. The company confirmed to OT that no timings have been set for other regions, but more details will be shared in due course.

The Abiliti Overnight ortho-k contact lenses are designed and fitted to match the eye based on its corneal shape, to temporarily reshape the cornea.

The company suggested that the Abiliti Overnight contact lenses are “optimised” through corneal topography, refractive error and other measurements connected to a fitting software that provides a precise measurement of the corneal shape, and guides the eye care professional through the fitting process.

The company suggested this supports practitioners with “consistent and successful first fit rates of approximately 90%.”

Xiao-Yu Song, global head of research and development at Johnson & Johnson Vision, called the FDA approval an “important milestone” in the company’s myopia commitments. He added: “We look forward to supporting parents and eye care professionals in their care of children with comprehensive resources, starting with Abiliti Overnight Therapeutic Lenses, and continuing with additional products and services to address the progression of myopia.”

The FDA approval follows a collaboration announced between Johnson & Johnson Vision and Menicon. The partnership aimed to bring forward therapeutic contact lenses for the treatment of myopia under the Acuvue Abiliti brand. The new brand focuses on future products, services and resources to address myopia.

Commenting on the announcement, optometrist Dr Moshe Mendelson, from Silicon Valley Eye Physicians, said: “The prevalence of myopia in children is increasing, and as optometrists we are on the front lines of this epidemic that may threaten the vision of future generations.”

Mendelson added that the FDA approval for Abiliti Overnight would provide practitioners and parents with more options for myopia management.

Earlier this year, the company released its myopia management guide to provide a research-based rationale for providing myopia control. The guide included recommendations for assessing, monitoring and treating myopia in children.