“The Dry Eye Foundation is warning against the use of certain eye drops marketed for use in the United States.
From ingredients that should not be included to ingredients that should be but are not, and improper storage and manufacturing, Sandra Brown, MD, Dry Eye Foundation board member and medical advisor, has been sounding the alarm since the beginning of 2022.
In April 2022, the Dry Eye Foundation alerted the FDA to 2 brands of unapproved biologic eye drops being distributed commercially as prescription drugs.
“We’ve been banging this drum since first quarter, early second quarter of 2022,” Brown said. “The exact safety issue is that you cannot put a multidose eye drop that does not contain preservative in a bottle.”
Brown explained the reasoning behind this sentiment, in that preservative-free eye drops need to be put into a bottle specifically designed for them.
“Recently, thankfully, they’ve developed a special type of dropper that can be used with preservative-free eyedrops,” she said. “You can usually, easily, identify the bottle because it’s got kind of a funny sort of square cap on it [and] is called a multi-dose preservative-free dropper, an MDPF dropper. You cannot take a non-preserved eye drop and put it in a standard bottle. Because it does not prevent backwash.”
Brown described backwash as when the tip of the dropper becomes contaminated, then you let go of the squeeze, the bottle sucks contaminated liquid back into the bottle.
This is one of the reasons preservative-free bottles cannot be put into ordinary bottles, as ordinary bottles do not protect against backwash, according to Brown.
The Dry Eye Foundation includes a list of products that it has concern over on its website. Currently, there are more than 30 brands and even more products that the foundation has listed as an “orange level alert.””
