FDA helps people close eyes — with weights

The Food and Drug Administration (FDA) is putting another weapon in the Sandman’s arsenal.

The FDA announced Friday it is relaxing the regulations on certain eyelid weights that are used to help people who have trouble blinking and shutting their eyes.

Eyelid weights help people with a rare condition known as lagophthalmos shut their eyes by gently applying downward pressure to the eyelid when they look down. Doctors can carefully attach these weights to the outside of the eyelid, or in some cases, surgically implant them inside the eyelid.

{mosads}”An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye,” the FDA wrote in the Federal Register. “The device is intended for the gravity-assisted treatment of lagophthalmos (incomplete eyelid closure).”

Medical experts say it is important for people to be able to close their eyelids because blinking keeps the eyes moist and clean, while the tears act as a natural antibiotic, killing viruses and bacteria. People who can’t close their eyes often suffer from dry eyes, struggle to sleep and, in extreme cases, contract ulcers and scarring.

Lagophthalmos is a form of facial paralysis that prevents people from completely closing their eyes, though some may be able to do so partially. Medical experts say it can be caused by infection, stroke, trauma or surgery.

One of the more common ways to treat lagophthalmos is to apply artificial tear eye drops several times each day. In severe cases, doctors may recommend eyelid weights.

The FDA decision will loosen the regulations to make it easier for external eyelid weights to get to market, while still maintaining stringent requirements on the weights that are implanted in people’s eyes.

“The increased risks associated with implanted eyelid weights are related to the need for the device to be provide sterile,” the FDA wrote, adding, “These risks are significantly reduced with external eyelid weight devices.”

The rule, which the FDA originally proposed in February 2013, goes into effect in 90 days.