FDA Approves Orthokeratology Contact Lenses For Myopia Management

The US Food and Drug Administration (FDA) has approved the first orthokeratology (ortho-k) contact lens for the management of myopia.

The approval was granted to Johnson & Johnson Vision for their ACUVUE Abiliti Overnight Therapeutic Lenses.

Myopia, or nearsightedness, is considered one of the biggest eye health threats in the 21st century.

Over half of the world population is expected to become myopic by the year 2050, with 1 billion people expected to have high myopia.

Children under 12 years old are most vulnerable to develop high myopia, with an increased risk of eye diseases later in life.

The Device

Data show the ortho-k lenses can be safe and effective when managing myopia, according to previous studies conducted.

The device is specifically designed and fitted to match a patient’s eye, using a unique corneal shape to temporarily reshape the cornea.

It is available in both spheric and toric designs, in order to correct different combinations of corneal topography, refractive errors, and other measures connected to the fitting software.

According to investigators, the software can help accurately guide an eye care professional, with a successful first fit rate of approximately 90%.

The approval includes both an overnight therapeutic lenses and overnight therapeutic lenses for astigmatism.

Data show the overnight therapeutic lenses have reduced the axial elongation of the eye in children with myopia by 0.28 mm on average, over a 2-year period.

Reaction

Xiao-Yu Song, MD, PhD, Global Head of Research & Development at Johnson & Johnson Vision, said the decision marked an “important milestone” in benefiting eye health in patients with myopia.

“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,” said Song in a statement.

Moshe Mendelson, OD, FIAO, an optometrist with Johnson & Johnson Vision, went on to call the increasing prevalence of myopia in children an “epidemic.”

“For too long we have relied on increasing the prescription of glasses for children, while having few resources to address the underlying disease and help change this worrying trajectory of eye health,” Mendelson said. “The FDA approval of Abiliti Overnight will provide eye care professionals and parents with more options to manage myopia.”

The ortho-k lenses are expected to be available in the US by the end of the year.