Common Questions
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Eye drops made from amniotic fluid.
According to the FDA’s Public Safety Notification issued on April 10, 2023, Regener-Eyes and StimulEyes are both made from amniotic fluid.
Note: When we first launched this site, we used the term biologic (or biological) eye drops to refer to any eye drops claiming to be derived from human reproductive materials such as amniotic fluid, placenta, or amniotic membrane. At the time, there was considerable confusion about the actual ingredients because the products did not contain ingredient lists, and the eye drop contents became even more bewildering when both companies changed their product descriptions in 4Q2022.
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No.
FDA issued a Public Safety Notification on 4/10/23 about these eye drops.
A critical concern from the standpoint of the Dry Eye Foundation is that Regenereyes and Stimuleyes are both advertised as preservative-free and are sold in simple multi-dose bottles, which provide no protection against bacterial contamination. This is unsafe packaging and violates federal law.
In the recent multi-state outbreak of Pseudomonas aeruginosa infections linked to Ezricare Artificial Tears, the CDC and FDA highlighted the same unsafe packaging feature in their public communications.
Learn more about bacterial contamination risks associated with inappropriate eye drop packaging at Dry Eye Foundation’s website eyedropsafety.org.
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No one knows whether Regener-Eyes or StimulEyes works, because no clinical trials have been conducted for them. (See clinicaltrials.gov to verify.)
FDA issued a Public Safety Notification on 4/10/23 stating among other things that “there are no assurances that the products are safe and effective for any disease or condition”.
Please see Sludge ™ for Dry Eye Foundation’s position on whether biologic eye drops have any potential to be effective based on, among others, how they are stored versus the types of proteins they claim to contain
Testimonials are not compelling reasons to believe in the efficacy of any drug. See The Placebo Effect for more information.
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No.
FDA issued a Public Safety Notification on 4/10/23 explaining, among other things, that these eye drops require and do not have FDA approval as biologic drugs. FDA also issued letters about this to Regener-Eyes and StimulEyes in October and November 2022 respectively.
Watch this video to better understand the background of this issue.
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Yes. It may appear that they are not active simply because FDA processes take a long time and so much of what they do does not show up publicly.
Here are steps FDA has taken that are in the public domain:
Please call or email the FDA for more information.
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No.
Serum tears are made from your own blood. Biologic eye drops are made from someone else’s placenta or amniotic fluid. Increasingly, manufacturers of biologic eye drops refuse to state what their eye drops are made of at all.
Serum tears are compounded in a pharmacy. Biologic eye drops are mass manufactured for national distribution.
Serum tears do not require FDA approval, because they are autologous and compounded. Biologic eye drops do require FDA approval, via a Biologics License Application, because they are biologic substances that are strictly regulated.
Serum tears are stored frozen, then temporarily refrigerated, because they contain complex proteins and other substances that are not stable at room temperature. Biologic eye drops are said to contain complex proteins, but are advertised as shelf stable at room temperature without evidence that the proteins remain active when stored that way.
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If you are using Regener-Eyes or StimulEyes, we recommend that you contact your eye doctor to discuss alternative treatments that can be legally sold and are packaged and labeled safely.