These products are represented by the manufacturers as compliant with FDA requirements, while in actual fact no clinical trials have ever been conducted and the manufacturers have never initiated the FDA approval process at all. There are numerous reasons to be concerned about the safety of these eye drops.

Astonishingly, these unstudied, untested, unapproved, potentially unsafe drugs, which cannot even be legally marketed, have somehow become mainstream dry eye fare in optometry and ophthalmology. Patients who are “prescribed” these costly eye drops - which have no ingredient list and cannot be purchased in a pharmacy - are typically wholly unaware of the lack of science, lack of FDA approval, and even lack of a safe bottle.

Patients who discover this information after having used biologic eye drops share the same story: They saw what they thought were red flags, but the eye doctor was recommending it, and they were desperate for relief, so they went ahead.

Predatory scam pharma in the form of regenerative medicine is masquerading as science, misleading patients and doctors, and exploiting the desperation of people suffering from chronic ocular surface pain.

UPDATE: On April 10, 2023 - one year and four days after we first alerted the FDA to Regener-Eyes - the FDA posted this statement: Public Safety Notification on Amniotic Fluid Eyedrops. We know they worked hard to reach that point are very pleased at this sign of progress.