FDA Clears Light-Sensitive Contact Lenses

Article

The contact lenses, which darken when exposed to strong UV light, were cleared through the 501(k) pathway.

The US Food and Drug Administration (FDA) has granted clearance for the first contact lenses with light-sensitive technology. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology incorporate an additive that reacts to bright light by darkening the lenses.

The Centers for Disease Control and Prevention estimates that 11 million Americans over age 12 have refractive vision errors and over 30 million Americans wear contacts to correct those errors. About 42 percent of Americans ages 12-54 are nearsighted, according to National Eye Institute, and 5% to 10% of Americans are farsighted.

The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are intended for daily use for people with myopia or hyperopia, and for people with certain degrees of astigmatism.

“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,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health said in a statement.

A Johnson & Johnson Vision Care, Inc, product, the lenses contain a photochromic additive that reacts to the amount of ultraviolet (UV) light present, slightly darkening the lenses in bright sunlight. The lenses automatically lighten again when exposed to darker or indoor conditions.

The FDA reviewed scientific evidence in clearing the contact lenses, including a clinical trial of 24 patients that investigated daytime and nighttime driving while using the light-sensitive lenses. The study results demonstrated no concerns with vision or driving performance while wearing the lenses.

The contacts are intended for use up to 14 days. As with regular contacts, patients should not expose the lenses to water or wear them while sleeping, and they should be worn as directed by a doctor.

The agency specifies that people with the following conditions should refrain from using these lenses: inflammation or infection in or around the eye or eyelids; any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids; any previously diagnosed condition that makes contact lens wear uncomfortable; severe dry eye; reduced corneal sensitivity; any systemic disease that may affect the eye or be made worse by wearing contact lenses; allergic reactions on the surface of the eye or surrounding tissues that may be induced or made worse by wearing contact lenses or use of contact lens solutions; any active eye infection or red or irritated eyes.

The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology have been cleared through the premarket notification 510(k) pathway.

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