The Food and Drug Administration (FDA) has sent letters to two manufacturers regarding their unlawful marketing of amniotic fluid eyedrops.
The FDA has not approved amniotic fluid eyedrops to treat any
diseases or conditions such as dry eye. The FDA is alerting the public that the manufacturers of Regener-Eyes Ophthalmic Solution and StimulEyes have been marketing and distributing amniotic fluid eye drops as a treatment for various eye conditions.
These drops have not been reviewed or approved by the FDA. Amniotic eyedrops can only be offered to patients if an investigational new drug (IND) application is in effect and and an IND is not in effect for these eye drops.
If patients experience any adverse events related to the use of amniotic fluid eyedrops, they need to report it to the FDA's MedWatch program. Health care providers are encouraged to report any adverse events as well.