Amniotic fluid eyedrops have not been approved to treat diseases or conditions such as dry eye by the Food and Drug Administration (FDA), according to a recent communication from the agency.
The alert was issued to inform the public that certain manufacturers have been marketing and distributing amniotic fluid eyedrops for use in the treatment of ophthalmic diseases and conditions that have not been reviewed or approved by the FDA. In late 2022, the agency sent letters to the manufacturers of Regener-Eyes® Ophthalmic Solution and StimulEyes to inform them that their products do not comply with the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, and other applicable regulations.
At this time, amniotic eyedrop products may only be offered to patients if an investigational new drug application (IND) is in effect. It is recommended that patients inquire about the status of the IND prior to consenting to treatment.
Patients and health care providers are encouraged to report any adverse events related to the use of amniotic fluid eyedrops to the FDA’s MedWatch program.
US Food and Drug Administration. Public safety notification on amniotic fluid eyedrops.. April 10, 2023. Accessed April 25, 2023. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-amniotic-fluid-eyedrops.