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Now available in eye drops!

A recent Health Canada advisory identified a previously unknown (to me) form of what looks like pseudoscience, as reported by CBC:

Regener-Eyes Ophthalmic Solution was being imported and sold by the Calgary Trail Vision Centre in south Edmonton. But this past Monday, Health Canada announced it was recalling this unauthorized product, because it claims to contain placenta materials. Health Canada is advising people not to use this eye drop, because it could pose a health risk due to potentially containing human placenta. Health products containing human placenta meet the definition of a drug under the Food and Drugs Act, as previously communicated in 2018 with the Placenta Pills Information Update. The Calgary Trail Vision Centre was directed to immediately stop importing and selling these eye drops.

If you’re like me, your first question was probably “Why?”
Digging into the story behind the story reveals some interesting science with stem cells, that not surprisingly, has been extrapolated into a dubious product that’s sold with a lot of claims but not much evidence to support it.

What is Regener-Eyes?

There isn’t much information about the exact formulation of Regener-Eyes on the manufacturer’s website. There is no indication that the product is FDA-approved, but it also lacks the Quack Miranda warning that you would see for supplements. This website claims that because Regener-Eyes is a “biological” that it doesn’t need FDA approval. Those who are more familiar with US regulations can let me know their thoughts in the comments, but I find it difficult to believe that a ophthalmic product that claims to contain various biologic growth factors escapes all federal regulation. It is claimed to be based, yes, on placenta-derived materials:

It is a bioengineered protein-based fluid, extracted from human placental-derived biomaterials. It is obtained from healthy, living donors with informed consent and full screening following, and exceeding, all FDA and AATB guidelines, collected via an AATB certified 501c3. All materials are from healthy pregnancies at the time of a scheduled C-sections; no ethical concerns.

They claim:

Regener-Eyes® contains naturally occurring anti-inflammatory cytokines, growth factors, and chemokines such as VEGF, TGFβ1, TGFβ3, EGF, HC-HA/PTX-C.PTX-3 (Pentraxin 3), IL-1Ra , PDGF, ST2, bFGF, KGF, Collagen Types I, III, IV, V and GDF11.

Apparently these growth factors are not drugs, which would probably surprise the pharmaceutical manufacturers that sell prescription growth factors. There are no specific indications noted, as you might expect for a drug. The manufacturer seems to imply it can be used for dry eyes, but also circumstances where there is irritation or inflammation. There are testimonials, but I couldn’t identify any published clinical trials in PubMed to substantiate any of the claims on the website. There is nothing resembling a placebo-controlled or head-to-head trial available, where the obvious comparison would be to plain lubricating eye drops. It should not be seen as a vote of confidence when a manufacturer of a medicinal product suggests you consult their Facebook reviews.

Not surprisingly, Health Canada blocked the sale of this product because of the web site statement that it is derived from human placenta.

Why the placenta?

Using placental-derived tissues isn’t completely implausible, but they are not a home run. The American Academy of Ophthalmology describes the use of amniotic membrane, a layer of the placental sac harvested after live Caesarean birth, to help heal eye injuries. The theory is that the amniotic membrane contains growth factors, and when the epithelium (the outer layer) is damaged, the growth factors (or some other component of the membrane) can promote healing. Prokera, a commercially-marketed product (and approved by regulators) fastens amniotic membrane to a polycarbonate ring (sort of like a contact lens) that can be used for moderate to severe dry eye where the cornea is injured. It uses tissue from an FDA-inspected tissue bank. While the hype may outpace the science, and results from randomized controlled trials are not impressive, there appears to be continued interest in its application. Notably, I could find no mention of placenta-derived drops to treat ophthalmic conditions – the research interest seems to be in the amniotic membrane.

Don’t put that placenta in your eye

Placenta-based eye drops that have been recalled by Health Canada are available via prescription in the United States, but appear to be sold in an unregulated state. Whether or not they provide any medicinal benefits hasn’t been shown in published randomized controlled trials. Their production and use is likely a consequence of broader interest in placental-derived products, and in particular, the ophthalmic use of amniotic membranes for serious eye injuries. Until some robust evidence emerges to show that placental-based eye drops are both safe and effective, it would seem to be a better strategy to rely on ophthalmic experts to guide the management of ocular injuries and disorders.

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Posted by Scott Gavura