FDA Approves Implantable Vision-Correcting Lens

The U.S. Food and Drug Administration (FDA) has approved Revision Optics Inc.’s Raindrop Near Vision Inlay device that corrects near vision for patients with presbyopia, providing an alternative for surgical, outpatient treatment of the disease.

The Raindrop is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery, and the first implantable device that changes the shape of the cornea to achieve improved vision. The device is made of a hydrogel material and resembles a tiny contact lens smaller than the eye of a needle.

To insert the device, an eye surgeon uses a laser to create a flap in the cornea of the patient's non-dominant eye, implants the device into the opening and puts the flap back in place. The inlay provides a steeper surface that can help the eye focus on near objects or print. The natural lens of the eye typically performs this function by changing shape, but in patients with presbyopia the lens becomes hardened and ineffective at focusing on close-up objects, which causes poor near vision. By reshaping the curvature of the cornea, the inlay corrects the refractive error that results in near vision problems.

Dr. William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, cited the aging of the baby boomer population as one demand driver for near-vision correction.

Revision Optics develops optical solutions for the treatment of presbyopia.