The new MPDF dropper has allowed Regener-Eyes to recall eye drops under the guise of exchanging them for a safer bottle.  However, an MDPF dropper will not protect consumers from serious harm due to bacteria or fungus in eye drops prior to first use.  Regenerative Processing Plant has been silent regarding its unresolved CGMP violations.

The Dry Eye Foundation continues to recommend against the use of Regener-Eyes Lite and Regener-Eyes Pro, regardless of bottle type or manufacture date.

Regener-Eyes LLC unofficially announced that it was recalling its preservative-free eye drops packaged in a standard bottle without a multi-dose preservative free (MDPF) dropper. Due to the informal nature of the recall, customary recall information that patients need to ensure their own safety was not provided: product names, manufacture dates, lot numbers, expiration dates, and photographs that help identify improperly packaged eye drops.  

The FDA sent the manufacturer of Regener-Eyes a warning letter on August 16, 2024. Here are some of the most concerning findings explained by DrB.

How to make sense of multiple Regener-Eyes facility inspections? The Regener-Eyes (Palm Harbor) manufacturing facility inspection was an "epic fail" but they've been quick to share that their Tampa storage facility was found to be compliant.

What's so unique about Regener-Eyes' ingredients if they've told the FDA the drops contain only salt, water and glycerin? How come eye doctors keep marketing these products?

Two new adverse event reports for Regener-Eyes released for 4Q23.

DrB asks, “What is Tonicity Solution Sodium Chloride?” and “How long can Regener-Eyes keep up the farce?”

The average cost for a glycerin-based eye drop in the US is $2.29 per mL ($22.90 for a 10mL bottle). Why exactly does Regener-Eyes cost between 10x and 30x the average?

Dry Eye Foundation obtained a copy of the complete inspection report (Form 483) for the manufacturer of Regener-Eyes through a Freedom of Information Act request.

Will the real Regener-Eyes please stand up?

Compare Regener-Eyes’ original vs revised descriptions submitted to the American Academy of Ophthalmology - and see the long history of contradictory statements about what is in Regener-Eyes.

An Open Letter from Dry Eye Foundation to M2Biologics: What is in Stimuleyes? Is the bottle safe?

An Open Letter from Dry Eye Foundation to Regener-Eyes LLC: Is the Regener-Eyes bottle safe?

FDA’s biologics internet surveillance team sent a letter on 11/17/22 to M2Biologics, the makers of StimulEyes (amniotic fluid eye drops) about their failure to obtain a biologics license.

Compare your sources (the manufacturer, your doctor, the FDA). Do everyone’s answers agree?

Dry Eye Foundation Board of Directors responds to an ongoing smear campaign.