Some developers and manufacturers are selling eye drops that have not been approved by the FDA.
The Food and Drug Administration issued a public safety notice advising that it has not approved the use of amniotic fluids in eye drops. The organization clarified that it had not approved the use of these drops to treat dry eye disease.
Amniotic fluid is a clear, yellowish liquid that surrounds a fetus during pregnancy. The fluid allows for the baby’s development and temperature maintenance and serves as a protective cushion.
The FDA said in its notice that because the products are not approved, an investigational new drug application (IND) must be in effect before a medical practitioner can offer this type of eye drop to patients. Patients would need to submit to a clinical trial in order to have this medication administered.
“Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the investigational procedure,” said the FDA in the notice.
FDA officials said that civilians who wish to submit to these trials should be aware of all risks involved and understand the entire process before submitting.
Despite the need for more testing, the product can still be found on shelves.
Examples of amniotic fluid eye drops that can be found in stores include Regener-Eyes Professional Strength, Regener-Eyes LITE, and StimulEyes, according to the Sjogrens Foundation.
“In addition, as these products are not FDA-approved, the agency does not have information about their manufacture, and there are no assurances that the products are safe and effective for any disease or condition,” said the FDA in its notice.
The FDA said it has made efforts to communicate with eye drop manufacturers using amniotic fluid and issued letters explaining that the drops have not been approved. The agency urges civilians and healthcare providers to report any adverse effects related to this product.
