First Gel For Cataract Surgery Approved By The FDA

By Cyndi Root

Physicians in the U.S. have a new method to seal incisions after cataract surgery. The Food and Drug Administration (FDA) has approved ReSure Sealant, a synthetic gel to protect corneal incisions after intraocular lens placement. Ocular Therapeutix, a privately held company in Bedford, Mass., manufactures the gel.

Christy Foreman, director of the Office of Device Evaluation at the FDA, said, “The FDA has approved gels like ReSure for sealing small incisions in other parts of the body, such as the lungs, but this is a first-of-its-kind for the eye.” The biocompatible hydrogel forms a soft but impermeable membrane that acts as a barrier to liquids leaking out and infections or debris getting in.

Cataracts

Cataracts are very common, especially as people age. Over half of Americans have cataracts or have had cataract surgery by the age of 80. A cataract is a cloudy lens, the area of the eye that focuses light on the retina. At the back of the eye, the retina records light and translates it to nerve signals. If the lens is cloudy, the brain interprets the image as blurry.

Cataract Surgery

The objective in cataract surgery is to replace the cloudy lens with an artificial lens, known as an intraocular lens implant (IOL). A patient can choose from different kinds of lenses including mono-focal and multi-focal, depending on his or her vision and future needs. Surgery is usually performed on an outpatient basis and takes about an hour. Anesthesia is typically local with the patient awake during surgery. Patients with cataracts in both eyes have two separate surgeries, as each eye needs time to heal. Currently, doctors use stitches to repair the incision.

Clinical Trials

The clinical trials of ReSure went well with no adverse events or major problems. Out of the 295 adults treated, only one person developed a leaking incision and needed stitches.  Researchers found ReSure more effective than sutures, but patients experienced the same amount of pain or discomfort from having a foreign entity in the eye.

ReSure Usage

To apply the gel, the surgeon mixes two liquids together and applies it with a foam-tipped applicator. The gel hardens within seconds. Within seven days, the gel breaks down and the body’s natural tears wash it away as the wound heals.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381139.htm