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#### Gross —

The FDA would like to remind you not to put amniotic fluid in your eyes
=======================================================================

Amniotic fluid is mostly just fetal urine—and it's not FDA-approved for eyes.
-----------------------------------------------------------------------------

[Beth
Mole](https://arstechnica.com/author/beth/) - Apr 20, 2023 7:56
pm UTC

![An inflamed
eye.](https://cdn.arstechnica.net/wp-content/uploads/2023/04/GettyImages-151042313-800x536.jpeg)
Enlarge
/ An inflamed eye.

Getty | BSIP


#### reader comments

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class="visually-hidden"> with 
#### Share this story

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For a sinister Shakespearian brew to conjure spirits, you're going to
need to gather a variety of mystical herbs, like the scale of a dragon
and the cool blood of a baboon (or maybe [a spotted
gecko](https://www.dictionary.com/e/witch-ingredients/)). For eternal
life, harvest a dead man's toe and a newt's saliva.

But if dry eye relief is all you seek, then the urine of a human fetus
is what you'll need—just don't mention it to the Food and Drug
Administration.

The regulatory agency posted [a public safety
notification](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-amniotic-fluid-eyedrops)
warning people not to use eye drops with such ingredients—products more
akin to hocus-pocus than modern medicine.

The eye drops are thought to contain amniotic fluid, the clear liquid
that surrounds and cushions a human fetus as it incubates in a womb.
Generally, [amniotic
fluid](https://www.ncbi.nlm.nih.gov/books/NBK541089/) contains a variety
of maternal and fetal excretions and secretions, but after the 10th week
of gestation, it is largely fetal urine, with fetal lung secretions
being another significant component.

Unapproved
----------

Makers of these tinkly eyedrops claim they can treat eye conditions,
namely dry eyes and inflammation. Any such biologic-based product
claiming to cure or treat a condition is regulated by the FDA under the
Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
As such, these products require an investigational new drug application
(an IND) to be tested in humans and a full FDA approval before hitting
the market.

This appears to have been news to at least two companies that the FDA
sent warning letters to late last year. The companies,
[Regener-Eyes](https://www.fda.gov/media/162219/download) and [M2
Biologics](https://www.fda.gov/media/163465/download), were illegally
selling unapproved eye drops, which the FDA said contained
amniotic-fluid, to treat dry eyes.

Advertisement 

In fact, there is not a single amniotic-fluid eye drop product approved
by the FDA, and any such product used under an IND requires patients to
sign consent forms. Yet, the FDA is finding these products on the
market, the regulator said in its notification.

"\[M\]anufacturers are marketing and distributing amniotic fluid eye
drops to treat, mitigate, or cure diseases or conditions such as dry eye
disease without the required premarket review and approval, raising
potential significant safety concerns," the agency warned.

Without the proper approvals and oversight, the agency noted that it
does "not have information about their manufacture, and there are no
assurances that the products are safe and effective for any disease or
condition."

And there's a good chance that they aren't effective. For years, some
researchers have touted the [potential regenerative and healing
properties](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474290/) of
amniotic fluid for eye conditions. And for decades, ophthalmologists
have used amniotic *membranes* for [repairing the surface of the
eye](https://eyewiki.aao.org/Amniotic_Membrane_Transplant)—with [mixed
results](https://www.nature.com/articles/eye2008410).

But, to date, only [one clinical trial of amniotic fluid eye
drops](https://pubmed.ncbi.nlm.nih.gov/36730463/) has been published—and
it found the drops were ineffective. The trial, published just last
month, was run by researchers at the Moran Eye Center at the University
of Utah. They looked at whether processed amniotic fluid could speed
recovery after a type of laser eye surgery called photorefractive
keratectomy (PRK), which is used to treat common vision problems. The
randomized, controlled trial involving 61 people found that amniotic
fluid was no better than placebo.

Blurry products
---------------

It's not a wild idea that amniotic components could help eyes. Amniotic
membranes are thought to support eye surface repair because the fetal
membrane has a similar cellular composition to the mucus membrane on the
surface of the eye. Moreover, amniotic tissue and fluid can contain
electrolytes, growth factors, enzymes, hormones, and immunoglobulins,
which can help spur cellular repair. But with any donated biological
material, there's variation and the risk of inadvertently transferring
pathogens; and with amniotic fluid, there's the fact that it's 98
percent water. In studies of amniotic membranes, researchers have come
up with mixed results, with successes in pilot studies vanishing in
larger randomized controlled trials.

Advertisement 

This apparently hasn't stopped some people from making strong claims
about the benefits of dripping amniotic fluid onto eyeballs. M2
Biologics claims its StimulEyes "regenerative eye solution" can soothe
dry eyes with "natural anti-inflammatory components." [The Georgia-based
company's website](https://www.m2biologics.com/) says that the eye
drops, which run $229 for a one-month supply, are currently unavailable
for sale.

Regener-Eyes, the other company called out by the FDA for selling
amniotic-fluid eye drops, still appears to be selling eye drops via "eye
care professionals." However, sometime last year it scrubbed its website
of details about what is in its eye drops. [An Internet Archive version
of its products
page](https://web.archive.org/web/20220519173126/https:/www.regenereyes.com/our-products/)
captured on May 19, 2022, shows that the Florida-based company promoted
its eye drops as a "natural, biologic" that contained "cytokines,
chemokines and growth factors  such as VEGF, TGFβ1, TGFβ3, EGF, IL-1Ra ,
PDGF, ST2, bFGF, KGF, GDF11, HC-HA/PTX3 (Pentraxin 3) (hyaluronic acid),
and Collagen Types I, III, IV, V."

Its [archived page on clinical
studies](https://web.archive.org/web/20210619005551/https:/www.regenereyes.com/clinical-studies-white-papers/)
noted publications on amniotic fluid and "amniotic derived therapies."
But, in terms of clinical studies of its own eye drops, the company
listed only informal, vague documents, such as [black-and-white
pictures](https://web.archive.org/web/20210625164739/https:/www.regenereyes.com/wp-content/uploads/2021/05/MGD-Case-Study-4-pt-M.-T..pdf)
of individual patients' eyes and a single graph of results from a
patient
[survey](https://web.archive.org/web/20210625164730/https:/www.regenereyes.com/wp-content/uploads/2021/05/speed_scores_and_vas_severity_scores-RNI.pdf),
none of which is published in a scientific journal or peer-reviewed.

All of that is now gone. The website [currently
states](https://www.regenereyes.com/our-products/) that its eye drops
are an "OTC Drug that is preservative free" and is "in compliance with
all Federal regulatory laws." It's unclear if the company changed the
formulation of the product or just changed its website. Regener-Eyes did
not respond to emailed questions from Ars.


#### reader comments

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Beth Mole Beth is Ars
Technica’s health reporter. She’s interested in biomedical research,
infectious disease, health policy and law, and has a Ph.D. in
microbiology.

**Email**  //
**Twitter** [@BethMarieMole](https://www.twitter.com/BethMarieMole)

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