The U.S. Food and Drug Administration (FDA) recently issued an alert to patients and health care practitioners about safety concerns surrounding amniotic fluid eye drops that have been marketed and distributed to treat or mitigate dry eye disease and similar conditions.
The FDA noted that manufacturers of the amniotic fluid eye-drop products of the brands Regener-Eyes and StimulEyes were sent letters in October 2022 (pdf) and November 2022 (pdf), respectively, notifying them that they did not have the required FDA review or approval to lawfully market their products or to deliver them to patients.
