FDA Warns of Improper Marketing of Amniotic Fluid Eye Drops for Dry Eye Disease

The FDA has issued a safety communication, warning against the improper marketing of amniotic fluid eye drops for the treatment of dry eye disease. The communication links to earlier letters to two manufacturers – makers of Regener-Eyes and StimulEyes – warning that the products would need an approved Biologics License Application (BLA) to stay on the market, or healthcare providers would need an investigational new drug (IND) application to deliver them to patients.

Unapproved Products Readily Available for Sale

Both products appear to be readily available for sale on the internet, with plenty of options on Google Shopping. Although StimulEyes maker M2 Biologics states on its homepage that online ordering of the product is currently unavailable, the product appears to be available for purchase through other channels. Neither Regener-Eyes CEO Randall Harrell, MD, nor M2 Biologics have responded to a request for comment.

Risks to Patients

The FDA has been getting tougher on “birth tissue” companies marketing products that allegedly contain stem cells and other biological materials that are derived from the placenta and umbilical cord. The agency has argued that these are biological products that need to be regulated as such. Such products pose risks to patients as they have not been tested in controlled clinical trials, and the safety and efficacy of such amniotic fluid products in the treatment of individuals with dry eye disease and other diseases have not yet been established.

Experts warn that “The drops likely contain hundreds of different fetal proteins and other substances, which don’t necessarily just do helpful things, so there are definite risks”. These possible tissue changes “may not be entirely reversible after stopping the drops. We just don’t know.” Any drug placed into the eye could end up “in systemic circulation so there could be risks outside of the eye. I’d also worry about risks of infection.” Therefore, it is important to treat these products as drugs and require robust clinical trial data before marketing them.

The FDA has urged healthcare providers to report any adverse events associated with amniotic fluid eye drops to its MedWatch program. More robust regulatory responses may be required to curtail such activity.