FDA clears Acuvue Oasys light-responsive contact lens

The FDA today cleared the first contact lens designed to darken when exposed to bright light, the Acuvue Oasys made by Johnson & Johnson (NYSE:JNJ).

The lens, which uses J&J’s Transitions 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 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.

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