Dry Eye Foundation Warns about Alarming Surge of Unsafe Eye Drops
Patients are at risk from over-the-counter eye drops made by unregulated companies
POULSBO, WASHINGTON – April 14, 2023 – Dry Eye Foundation today is warning the public and healthcare providers about a sharp rise in eye drops marketed in the United States that may pose health risks to consumers. The CDC and the FDA have issued unusual safety warnings for four brands this year. Dry Eye Foundation has identified an additional seven brands of concern, encompassing 19 products. Product alerts and educational materials about red flags for eye drop safety are available at eyedropsafety.org, a Dry Eye Foundation website.
Potential hazards are increasing for people buying eye drops, from low-cost generics to eye drops marketed as “natural” and even costly “regenerative” eye drops. Digital marketplaces are being flooded with eye drops that are not listed with the Food and Drug Administration, and they appear side by side with established, compliant brands. “We have been warning for quite some time about the dangers of unscrupulous companies making or reselling eye drops,” said Dr. Sandra Brown, Dry Eye Foundation board member and medical advisor. “An artificial tear took three lives. Some people lost their vision, some lost an eye. It’s tragic - and it could happen again.”
Eye drops for dry eye disease are big business. Manufacturer revenues from the sale of dry eye products in the US are estimated at $2.1 billion in 2023, and $533 million of that will be from over-the-counter lubricant eye drops, according to Market Scope LLC. “Everyone wants a piece of this market,” said Rebecca Petris, Dry Eye Foundation’s Executive Director. “Today, a new breed of company is either feigning compliance or blatantly ignoring the rules. No one even knows where many of these eye drops are made. We’re creating resources to help consumers distinguish safe eye drops from eye drops with unknown risks.”
Eye drop safety issues are not new to Dry Eye Foundation. In April 2022, Dry Eye Foundation alerted the Food and Drug Administration to two brands of unapproved biologic eye drops being distributed commercially as prescription drugs. Sterility concerns about these eye drops’ packaging prompted a public education campaign at biologiceyedrops.org. On April 10, 2023, FDA issued a Public Safety Notification warning patients and healthcare practitioners about these brands.
“Consumers need reliable, informed sources to help them assess the eye drops they encounter online,” said Petris. DryEyeZone, a Dry Eye Foundation website, has long been a leader in over-the-counter eye drop information. In the past year, Dry Eye Foundation has developed additional websites biologiceyedrops.org and eyedropsafety.org to address new safety issues.
The Dry Eye Foundation
The Dry Eye Foundation is a 501(c)(3) nonprofit organization based in Poulsbo, Washington.
Its mission is to improve patients’ quality of life through community support services, education, research and advocacy programs. “Dry eye” is routinely dismissed as a minor nuisance. By contrast, the ocular surface diseases and ocular surface pain disorders that many patients face have profound functional, financial and emotional impact. Dry Eye Foundation is working to restore hope, redefine disease and reshape the future for people with these conditions.
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Aidan Moore
Rebecca Petris
800-484-0244