‘No Assurances’: FDA Warns Against Using Eye Drops With Amniotic Fluid

Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

U.S. drug regulators are warning people against using eye drops that have amniotic fluid, as no such products are approved for usage in the United States.

Some companies are promoting and selling amniotic fluid eyedrops anyways, claiming they help treat, mitigate, or cure issues such as dry eye disease.

“There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect,” the U.S. Food and Drug Administration (FDA) said in an April alert.

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“In addition, as these products are not FDA-approved, the agency does not have information about their manufacture, and there are no assurances that the products are safe and effective for any disease or condition,” the agency said.

The promotion and distribution of the products have been “raising potential significant safety concerns,” according to the FDA.

Regulators have been trying to crack down on companies selling the eyedrops without FDA clearance. In late 2022, they sent letters to M2 Biologics LLC and Regener-Eyes LLC, two manufacturers that have been promoting unapproved products as able to treat dry eye disease.

However, the products the companies sell are still available to order on various websites on the internet. The companies did not respond to requests for comment.

People who are considering using amniotic fluid eyedrops should take steps to verify whether the products have been cleared by the FDA, the agency recommends.

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“Ask if the FDA has reviewed the treatment. You also can ask for the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication stating that the IND is in effect,” the agency stated. “Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information.”

Amniotic fluid is the substance that surrounds the embryo and fetus during pregnancy. The fluid could potentially help heal eye problems, researchers have said. But a clinical trial examining amniotic fluid eye drops concluded the drops did not improve healing or reduce pain.

Paul Knoepfler, a professor at the University of California Davis, told MedPage Today that the products could contain substances that could harm the eyes.

“The drops likely contain hundreds of different fetal proteins and other substances, which don’t necessary just do helpful things, so there are definite risks,” he said. “For example, I could imagine a risk of abnormal blood vessel or other undesired tissue growth in the eye after using such drops due to growth factors in the drops.”

Health care providers are being told to report adverse events related to the use of amniotic fluid eyedrops, as well as any other products regulated by the FDA, to an FDA adverse event reporting system called MedWatch. Consumers can also lodge reports with the system.