FDA Issues Safety Concerns Over Amniotic Fluid Eye Drops

'There are currently no FDA-approved amniotic fluid eye drops to treat, mitigate, or cure eye diseases or conditions'

A close-up of a closed eye. Archive Photos/Getty Images

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.

According to the public safety notification from the FDA earlier in April, there are currently no amniotic fluid eye drops that the FDA has approved to treat any eye diseases or conditions.

Amniotic fluid is a liquid that surrounds the unborn baby during pregnancy, contained in the amniotic sac.

The federal agency warned patients and health care practitioners that because the amniotic fluid eye drops out there are not FDA-approved, it doesn’t have any information about how they are being manufactured and, therefore, “there are no assurances that the products are safe and effective for any disease or condition.”

According to the FDA, such eye drops “are regulated as drugs and biological products ... and are subject to premarket review and approval requirements.” For a health care practitioner to lawfully offer these products to patients, an investigational new drug application (IND) must be in effect. Furthermore, for a biological product to be marketed lawfully, an approved biologics license application (BLA) must be in effect.

The FDA letter to Regener-Eyes CEO Dr. Randall Harrel said the company had stated on its website that the eye drops are used to treat dry eye disease and is a “biological product” that contains “placental-derived biomaterials.” The company had also described Regener-Eyes as an “acellular” biological product, which means it doesn’t contain stem cells.

Meanwhile, the letter to M2 Biologics, the manufacturer of StimulEyes, said the company stated on its website that StimulEyes was a “regenerative medicine” to treat dry eye disease.

Harrel and M2 Biologics did not immediately respond to separate requests for comment from The Epoch Times.

Dry eye disease is a multifactorial disease that affects the tears and surface of the eyes, such that the tear film becomes unstable and the eyes’ surface may become damaged over time. Dry eye disease causes discomfort and disturbs the patient’s vision.

Depending on the nature and severity of the condition, patients are offered different treatments to restore tear film stability, or maintain the normal amount of tears in the eyes, to prevent discomfort and ocular surface damage.

The FDA said in its notice that patients and health care professionals “should report any adverse events related to the use of amniotic fluid eye drops” to the FDA’s MedWatch Adverse Event Reporting program.

Patients with dry eye disease who are considering using amniotic fluid eye-drop products in the United States are advised to ask their health care provider whether the FDA has reviewed the treatment.

“You also can ask for the FDA-issued [IND] number and the chance to review the FDA communication stating that the IND is in effect. Ask for this information before getting treatment and follow up with your personal health care provider to confirm this information,” the FDA states.