Hi there, I am sorry to hear that you were given incorrect information about Regener-Eyes. A lot has happened since I made this video back in 2022. Here are a couple of highlights. - In Aug/Sept 2022, Regener-eyes completely retooled all its advertising and its website and eliminated all mention of biologic ingredients or functions. They also changed from describing it as a prescription drug to describing it as an over-the-counter lubricant. (Please be aware that over-the-counter eye drops listed in the FDA database are generally not subject to any regulatory scrutiny at all due to the unique and outdated regulatory structure.) - In April 2023, the FDA issued a warning about amniotic fluid eye drops, specifically naming Regener-Eyes. - In June 2023 FDA inspected the manufacturing facility. We obtained a copy of the inspection report through a Freedom of Information Act request and the results were extremely disturbing, from the poor manufacturing quality and safety standards to all the "disappearing" records and samples. We also noticed that they told the FDA they had stopped using amniotic fluid in 2021. However, as you yourself have experienced, doctors are still telling people otherwise... in 2024. Some steps you may wish to takeL 1) Call the FDA's biologics division at 800-835-4709 option 1 and share your experience. 2) Share the following documents with your eye doctor. I think that the Form 483 is the most compelling, personally. No matter what eye doctors think about the concept of amniotic fluid eye drops, most are very cautious when it comes to potentially contaminated manufacturing facilities. - Form 483 from their inspection. static1.squarespace.com/static/62833cd80db3b342245285af/t/667c32f3cd81af569a395791/1719415542604/RPP+Form+483.pdf - Drug label for Regener-Eyes Pro . This shows it contains glycerin, sodium chloride (salt) and water. dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e689001a-3640-1d45-e053-2995a90a4032 - Public Safety Notification about Regener-Eyes and StimulEyes eye drops. Stimuleyes eye drops were withdrawn from the market after this FDA notice, but Regener-eyes continued. www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-amniotic-fluid-eyedrops From all the reports that we hear from both eye doctors and customers, this is a very aggressive, clever and unscrupulous company.
I am, well was up until today, on Regener Eyes Lite. Started around the first week of October 2023. My eye Dr gave it to me as a stem cell drop. Or that’s what I thought he said. Stopped today bc I looked up the weird side effects I’m having and gasped!
@@DryEyeFoundation I just got off the phone w the FDA & they said to get my eyes checked bc I feel pressure & have been getting headaches. Ugh! I feel like my Dr & I were scammed.
Those are definitely symptoms that you want to get checked out. And they might be completely unrelated to the drops anyway (timing coincidences do happen!) Wishing you the best! @@Cath6Rob
@@DryEyeFoundation I had a similar reaction to another eye drop and an oral medication. There is a filler or inactive ingredient that I must be allergic to but I can’t get answers from Regener-eyes so far. Hypromellose is in both so I’m wondering if it’s in this drop too. Thank you for your reply. 🤗
Wow that's interesting. Please let us know if we can help. 800-484-0244. It's tricky tracking down ingredient allergies, especially amongst inactives. Obviously, harder when companies do not actually disclose ingredients. *If* Regenereyes' labeling is accurate, it contains glycerin and saline. - We are not aware of any suggestion that it contains hypromellose. Couple of resources on ingredients: Inactive ingredient info for eye drops: www.dryeyezone.com/drbs-blog/glossary-of-eye-drop-ingredients Look up ingredients of any OTC eye drops in US alerts.eyedropsafety.org/ @@Cath6Rob
This crap has FINALLY been taken off the market! It took the FDA long enough to enforce basic drug safety laws but at least they finally did it. I wish there was punitive action or even criminal charges against those in charge for brazenly and knowingly committing fraud and violating drug safety laws.
We're curious what gives you the impression it's been taken off the market? It's still available for sale in all the places that it was, and we're still hearing from patients whose doctor recommended or sold it to them quite recently. We strongly share your sentiments about justice for this dangerous fraud.The FDA processes are slow and they are hampered by frankly not having enough authority to take decisive steps. They will probably have to have a court order, ultimately, to put a stop to this.
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Has anything changed in the past year? I was given Regener-Eyes by my eye doc just yesterday (6-24-24) and told they contain amniotic fluid.
Hi there,
I am sorry to hear that you were given incorrect information about Regener-Eyes.
A lot has happened since I made this video back in 2022. Here are a couple of highlights.
- In Aug/Sept 2022, Regener-eyes completely retooled all its advertising and its website and eliminated all mention of biologic ingredients or functions. They also changed from describing it as a prescription drug to describing it as an over-the-counter lubricant. (Please be aware that over-the-counter eye drops listed in the FDA database are generally not subject to any regulatory scrutiny at all due to the unique and outdated regulatory structure.)
- In April 2023, the FDA issued a warning about amniotic fluid eye drops, specifically naming Regener-Eyes.
- In June 2023 FDA inspected the manufacturing facility. We obtained a copy of the inspection report through a Freedom of Information Act request and the results were extremely disturbing, from the poor manufacturing quality and safety standards to all the "disappearing" records and samples. We also noticed that they told the FDA they had stopped using amniotic fluid in 2021. However, as you yourself have experienced, doctors are still telling people otherwise... in 2024.
Some steps you may wish to takeL
1) Call the FDA's biologics division at 800-835-4709 option 1 and share your experience.
2) Share the following documents with your eye doctor. I think that the Form 483 is the most compelling, personally. No matter what eye doctors think about the concept of amniotic fluid eye drops, most are very cautious when it comes to potentially contaminated manufacturing facilities.
- Form 483 from their inspection.
static1.squarespace.com/static/62833cd80db3b342245285af/t/667c32f3cd81af569a395791/1719415542604/RPP+Form+483.pdf
- Drug label for Regener-Eyes Pro . This shows it contains glycerin, sodium chloride (salt) and water.
dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e689001a-3640-1d45-e053-2995a90a4032
- Public Safety Notification about Regener-Eyes and StimulEyes eye drops. Stimuleyes eye drops were withdrawn from the market after this FDA notice, but Regener-eyes continued.
www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-amniotic-fluid-eyedrops
From all the reports that we hear from both eye doctors and customers, this is a very aggressive, clever and unscrupulous company.
I am, well was up until today, on Regener Eyes Lite. Started around the first week of October 2023. My eye Dr gave it to me as a stem cell drop. Or that’s what I thought he said. Stopped today bc I looked up the weird side effects I’m having and gasped!
So sorry to hear that! Please be sure to report your experience to the FDA.
www.biologiceyedrops.org/report-adverse-events
@@DryEyeFoundation I just got off the phone w the FDA & they said to get my eyes checked bc I feel pressure & have been getting headaches. Ugh! I feel like my Dr & I were scammed.
Those are definitely symptoms that you want to get checked out. And they might be completely unrelated to the drops anyway (timing coincidences do happen!) Wishing you the best! @@Cath6Rob
@@DryEyeFoundation I had a similar reaction to another eye drop and an oral medication. There is a filler or inactive ingredient that I must be allergic to but I can’t get answers from Regener-eyes so far. Hypromellose is in both so I’m wondering if it’s in this drop too. Thank you for your reply. 🤗
Wow that's interesting. Please let us know if we can help. 800-484-0244. It's tricky tracking down ingredient allergies, especially amongst inactives. Obviously, harder when companies do not actually disclose ingredients. *If* Regenereyes' labeling is accurate, it contains glycerin and saline. - We are not aware of any suggestion that it contains hypromellose.
Couple of resources on ingredients:
Inactive ingredient info for eye drops:
www.dryeyezone.com/drbs-blog/glossary-of-eye-drop-ingredients
Look up ingredients of any OTC eye drops in US
alerts.eyedropsafety.org/
@@Cath6Rob
This crap has FINALLY been taken off the market! It took the FDA long enough to enforce basic drug safety laws but at least they finally did it. I wish there was punitive action or even criminal charges against those in charge for brazenly and knowingly committing fraud and violating drug safety laws.
We're curious what gives you the impression it's been taken off the market? It's still available for sale in all the places that it was, and we're still hearing from patients whose doctor recommended or sold it to them quite recently.
We strongly share your sentiments about justice for this dangerous fraud.The FDA processes are slow and they are hampered by frankly not having enough authority to take decisive steps. They will probably have to have a court order, ultimately, to put a stop to this.