FDA warns against use of unapproved amniotic fluid eye drops

The FDA issued a public safety notification earlier this month that warned of potential safety concerns with the marketing and distribution of amniotic fluid eye drops—for conditions such as dry eye disease (DED)—that have not received required pre-market review and approval.

Talk about these drops.

Amniotic fluid eye drops are regulated as drugs or biological products under the FDA’s protocols; in order to be FDA-approved for testing, mitigating, or curing disease, the drops would need to have an investigational new drug application (IND).

To be marketed, they would require a Biologics License Application (BLA).

According to the FDA, there are currently no amniotic fluid eye drops that have been approved for testing, mitigating, or curing diseases.

And this notification?

In its communication, the FDA warned that, given the drops’ unapproved status, the agency has no information regarding their manufacturer—meaning it’s not able to assure their safety and efficacy for diseases or conditions.

So what brought this on?

In late 2022, the FDA sent letters to two eye care product manufacturers—Regener-Eyes LLC and M2 Biologics LLC—regarding their improperly-marketed amniotic fluid eye drop products: Regener-Eyes Ophthalmic Solution and StimulEyes, respectively.

The agency warned that the products being advertised as a “biological product” (Regener-Eyes) and a “regenerative medicine” (StimulEyes) for DED would require an approved BLA in order to stay on the market or an IND to deliver them to patients.  

Have the companies complied?

M2 Biologics has removed StimulEyes from the market to comply with the updated FDA regulations. "When StimulEyes was introduced to the market in the summer of 2020, it was compliant with the PHS Act Section 361 and 21 CFR Part 1271 requirements for HCT/Ps," Roger Hitt, Chief Operating Officer of M2 Biologics, stated in a May 1 email to Glance.

"[We] have voluntarily removed StimulEyes from the marketplace and are working on a formulation that will comply with the current regulatory framework."

While the products are listed on the M2 Biologics website, online ordering is unavailable.

Regener-Eyes Ophthalmic Solution was awarded an over-the-counter (OTC) drug indication to relieve dryness of the eye in August 2022.

The OTC Monograph was the subject of a final administrative order by the FDA, meaning that the non-prescription drug is "generally recognized as safe and effective (GRASE) for its intended use."

Now what?

The FDA is advising patients and eye care providers to report any adverse events tied to the use of amniotic fluid drops to its MedWatch Adverse Event Reporting program.

To file a report, click here.