FDA Approves Implant for Nearsightedness

The US Food and Drug Administration (FDA) today approved a device implanted in the cornea of one eye for some patients with presbyopia. It will not work if patients do not have clear distance vision.

It is the second FDA-approved implantable corneal device for correction of near-sightedness. It is meant only for patients who have not had cataract surgery, the FDA noted.

The devices is marketed as the Raindrop Near Vision Inlay. It is made by Revision Optics, Inc. of Lake Forest, CA.

The device is not for patients with severe dry eye, active eye infection, corneal disease characterized by general thinning and cone-shaped protrusion in the center of the cornea, and certain other conditions including uncontrolled diabetes.

The implant proved safe and effective in a clinical trial of 373 patients of whom 92% were able to see with 20/40 vision or better at near distances with the inlay.

According to the FDA, the implant could be an alternative to reading glasses or bifocals.