FDA shares safety warning on amniotic fluid eyedrops

pharmafile | April 26, 2023 | News story | Medical Communications  

The US Food and Drug Administration (FDA) has released a Public Safety Notification on eyedrops containing amniotic fluid currently being sold to treat, mitigate or cure diseases or conditions including dry eye disease.

This safety notice links to earlier letters to two manufacturers, Regener-Eyes and StimulEyes, which warned that they would need an approved Biologics License Application (BLA) for these products to be kept on the market, otherwise an investigational new drug (IND) application would be needed.

According to the FDA’s notice: “As a general matter, amniotic fluid eyedrops used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and are subject to premarket review and approval requirements. There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions […] 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.”

The FDA states that it has “taken steps to notify manufacturers marketing amniotic fluid eyedrops regulated as drugs and biological products without FDA review or approval. […] FDA remains committed to protecting patients from unapproved and unproven products and to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.”


Betsy Goodfellow

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