FDA cautions against use of eye drops containing amniotic fluid
The US Food and Drug Administration has issued a public safety notification about unapproved eye drops containing amniotic fluid
12 May 2023
The US Food and Drug Administration (FDA) has cautioned members of the public against purchasing eye drops that contain amniotic fluid.
In a public safety notification published in April, the FDA highlighted that there are currently no FDA-approved eye drops containing amniotic fluid.
“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 notice highlighted.
The FDA shared that the administration is aware of manufacturers that are marketing and distributing amniotic fluid eye drops claiming to treat, mitigate or cure diseases such as dry eye disease.
In 2022, the FDA published on its website two letters to manufacturers of eye drops for dry eye disease that appear to contain biological products. A letter to M2 Biologics was published in November and a letter to Regener-Eyes was published by the FDA in October.