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FDA Raises Safety Concerns Over Unapproved Eye Drops Containing Amniotic Fluid

A recent public safety notification warns that eye drops being marketed as disease treatments have not been proven safe or effective.




The U.S. Food & Drug Administration recently released a notification warning the public and health care practitioners against using, or suggesting the use of, eye drops with amniotic fluid to cure diseases.

Currently, the FDA has yet to approve any “amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions.”

That hasn’t prevented manufacturers from marketing and distributing amniotic fluid eye drop products as effective and safe treatments for various eye ailments, most notably dry eye disease.

FDA Raises Safety Concerns Over Unapproved Eye Drops Containing Amniotic FluidThe FDA sent letters to two companies in late 2022 explaining that their products require federal approval to remain on the market. Regener-Eyes LLC received its letter in October. M2 Biologics LLC received its letter in November.

According to the FDA, Regener-Eyes was marketing its product, Regener-Eyes Ophthalmic Solution, as a ‘“natural, ophthalmic solution,” described as an “acellular” “biological product” that is composed of “placental-derived biomaterials.”’

Similarly, the FDA found M2 Biologics LLC marketed its product, StimulEyes, as “a regenerative medicine solution for dry eyes.”


Both letters included this portion:

“In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect. Such licenses are issued only after a demonstration that the product is safe, pure, and potent.”

In its public safety notification, the FDA warns that since these products have yet to gain FDA approval, it has no way of determining how these products are manufactured, what they are made of, and how effective and/or safe they are for human usage.

There is no mention on the respective company websites that the products in question are biological products. However, in a press release dated May 2021, Regener-Eyes touted its product as “a first-in-class biologic eye drop made of naturally occurring cytokines and growth factors.” Another press release from February of 2021, this one from ABB Optical Group, a major optical products distributor, had this to say about Regener-Eyes: “a sterile, biologic eye drop made of anti-inflammatory cytokines and growth factors, is the newest product in ABB’s dry eye treatment lineup.”

On its website, Regener-Eyes touts “an excellent safety profile” and says it “is in compliance with all federal regulatory laws.” The Florida company also lists a clinical advisory board that includes four ophthalmologists and six optometrists. ABB Optical Group continues to promote Regener-Eyes as a dry eye treatment, endorsing the product as “a first in class, natural, sterile ophthalmic solution that is preservative-free and is available to ship directly to your patient.”

The M2 Biologics website says that “StimulEyes eye drops have natural, scientifically studied ingredients.” Also, the company states that its product (has the) same formulation as used by eye care professionals. However, there is a disclaimer in small print at the bottom the site that reads, in part: “StimulEyes is not intended to diagnose, treat, cure, or prevent any disease.”


The FDA asks health care providers to report any “adverse events” concerning amniotic fluid eyedrops to the FDA’s MedWatch Adverse Event Reporting program.


The FDA: “Public Safety Notification on Amniotic Fluid Eyedrops”

ABC News: “Be wary of unproven eye drop treatment with amniotic fluid, FDA says”

The Dry Eye Foundation: “Open Letter to Regenerative Processing Plant LLC”





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