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The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions. On April 10th, the U.S. Food & Drug Administration (FDA) made an announcement to inform consumers that some manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns.

There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect. In addition, as these products are not FDA-approved, the agency does not have information about their manufacture, so no assurance is available showing that the products are safe and effective for any disease or condition.

Examples of Amniotic Fluid Eye Drops include:

  • Regener-Eyes Professional Strength

  • Regener-Eyes LITE

  • StimulEyes

Patients using amniotic fluid eye drops can report adverse effects by clicking here.

Click here to view FDA Public Safety Notification

For information about previous Eye Drop Recalls, click the links below:

CDC: Recommendation to stop use of EzriCare Artificial Tears