Research & Development
The US FDA awards clearance to first contact lens with light-adaptive technology
11 April 2018 -

Public health company The US Food and Drug Administration stated on Tuesday that it has granted approval for the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light.

The US FDA has granted clearance of the Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology to Johnson & Johnson Vision Care Inc.

According to the company, the Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who are nearsighted (myopia) or farsighted (hyperopia). They can be used by people with certain degrees of astigmatism, an abnormal curvature of the eye.

Prior to the approval, the US FDA reviewed the Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology through the premarket notification 510(k) pathway. The scientific evidence included a clinical study of 24 patients in daytime and nighttime driving performance while wearing the contact lenses. The study demonstrated there was no evidence of concerns with either driving performance or vision while wearing the lenses.

The company said the contact lenses contain a photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of UV light to which they are exposed. This results in slightly darkened lenses in bright sunlight that automatically return to a regular tint when exposed to normal or dark lighting conditions. These contacts are intended for daily wear for up to 14 days. These contacts should not be used as substitutes for UV protective eyewear.

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