UPDATED April 11, 2018, with comment from J&J.
The lens, which uses Transitions Optical’s light-intelligent technology, contains a photochromic additive that reacts to the amount of ultraviolet light it’s exposed to, according to the federal safety watchdog, which granted 510(k) clearance for lenses to treat both myopia and hyperopia.
The FDA said it based the clearance on a 24-patient study examining daytime and nighttime driving performance by patients wearing the light-sensitive lenses.
“The results of the study demonstrated there was no evidence of concerns with either driving performance or vision while wearing the lenses,” the agency said.
“This contact lens is the first of its kind to incorporate the same technology that is used in eyeglasses that automatically darken in the sun,” added Malvina Eydelman, director of the CDRH’s ophthalmic & ENT devices division, in prepared remarks.
Johnson & Johnson said it plans to make the Acuvue Oasys lenses available in the U.S. during the first half of 2019.
“This innovation was born out of deep research into consumer lifestyle needs and fits our future-forward approach to caring for human sight,” J&J Vision R&D head Dr. Xiao-Yu Song said in prepared remarks. “Acuvue Oasys with Transitions creates and defines an entirely new category of contact lenses that will address unmet needs for patients. After more than a decade of product development and numerous clinical trials involving more than 1,000 patients, we are excited to bring to market a solution to help contact lenses wearers manage the changing light conditions they face every day in their modern, active lives.”
Johnson & Johnson paid $4.33 billion to acquire Abbott Medical Optics in February 2017 and added TearScience to the J&J Vision portfolio in September of last year.