Timeline & references

  • On April 5, 2023 the Dry Eye Foundation first communicated via email with the Food and Drug Administration about the drug listings for Regener-Eyes “ophthalmic solutions”. We exchanged additional emails in the course of the month.

    We informed them, among many other things, that we had discovered that these eye drops are preservative-free but packaged in simple multi-dose bottles which offer no protection against bacterial contamination after opening, and that we were concerned about patient safety.

    We also informed them that while these products are marketed as biologic eye drops requiring a doctor’s prescription, they are also listed as glycerin-based eye drops in the FDA’s own non-prescription drug database, searchable at https://dailymed.nlm.nih.gov/dailymed/.

    At that time, the drug listings contained an ingredient called “d-MAPPS”, which some medical references describe as amniotic fluid. However, there is no such ingredient in the FDA’s ingredient database.

    FDA’s biologics division (CBER) informed us that these eye drops require a Biologics License Application, which is the drug approval process for biologic drugs. They also informed us that the company had never applied for such a license. They did not comment on the OTC listings, which fall under the jurisdiction of another part of the FDA’s non-biologic drug division (CDER).

  • An Open Letter for Eye Care Professionals

  • Regulatory Compliance Status of Certain Commercial Biologic Eye Drops

  • Open Letter to Regenerative Processing Plant

    This letter to the manufacturer of Regener-Eyes, which asks them to tell us what is in Regener-Eyes eye drops, was copied to all the relevant FDA department heads.

  • Untitled Letter

  • On October 24, 2022 we wrote to the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance - specifically, the Office of Unapproved Drugs and Labeling Compliance.

    We explained our concerns about Regener-Eyes OTC drug listings, and requested action to address them.

    We wrote again on November 6 to confirm that the message was received. It was confirmed on November 7, but to date, no other response has been received.

  • Open Letter to Regenerative Processing Plant

    This letter to the manufacturer of Regener-Eyes was written a month after the recall of EzriCare Artificial Tears. In this letter, we asked RPP about the safety of their preservative-free eye drop packaged in a simple bottle. The letter copied to all the relevant FDA department heads.

  • Public Safety Notification on Amniotic Fluid Eye Drops

  • Open Letter to the Food and Drug Administration

    Nearly a month after the FDA’s public warning about Regener-Eyes and StimulEyes (which, incidentally, ended all doubt about whether Regener-Eyes eye drops contain amniotic fluid), the OTC drug listings for Regener-Eyes were still active.

    We wrote again, this time in an Open Letter, urging FDA’s Office of Unapproved Drugs and Labeling Compliance to remove these misleading listings.