FDA Flags Improperly Marketed Amniotic Fluid Eye Drops

HOT TOPIC

The FDA recently issued a statement regarding amniotic fluid eye drops being improperly marketed for dry eye disease. The statement links to earlier letters sent to manufacturers warning that these products would need an approved Biologics License Application (BLA) to stay on the market, or else doctors recommending them to patients would need an investigational new drug (IND) application to deliver them to patients.

In the statement, the FDA noted that, “There are no assurances that the products are safe and effective for any disease or condition” and that there are “currently no FDA-approved amniotic fluid eyedrops to treat, mitigate, or cure eye diseases or conditions.” (Read more.)

According to Paul Knoepfler of the University of California Davis, who specializes in the stem cell industry, “these products still could contain growth factors and other substances that could have activity in the eyes.” He added that there are good reasons to treat these products as drugs, and, thus require robust clinical trial data before marketing.

My Two Cents

I was an early adopter of this class of drops for patients who had difficulty getting prescription medications. However, I eventually discontinued their use. One of the first red flags for me was the marketing of the drops as “preservative-free,” despite their being dispensed in a normal bottle requiring preservatives. It was also difficult for me to ascertain what was in the drops themselves, which should never be the case!

OUTSIDE THE LANE

Human-Like Behavior in the Animal World

Photo courtesy of amish_novelty/reddit.

Viral videos aren’t usually my thing; however, this one is both too cute and too eye-related not to share this week. In it, an elephant is shown simply rubbing its eye. That’s it. Just a gentle giant likely having an issue with some allergic conjunctivitis or potentially a small amount of dust or dander. Here’s hoping there is an optometrist nearby with some good preservative-free artificial tears or an antihistamine drop!

CAN YOU RELATE

On Thursday mornings, each doctor at Williamson Eye Center gets an email letting us know how we did the past week. Not how we did financially, but rather our “calibrator” score, which is determined by how our patients rank us, our team, and the practice as a whole. We have found that, as the health care system continues to become more consumerized, notably in our optometric profession, the importance of creating an excellent patient–consumer experience has come to the forefront of our practice and has allowed us to grow exponentially.

The calibrator score allows our physicians and management teams to see how we’re doing in real time. If a patient has a bad experience and lets us know about it by giving us a poor score, it triggers a message to our marketing team, and we all instantly go to work to make sure that patient’s problem is identified and, hopefully, resolved.

The system is quite straightforward. Immediately after the patient’s visit, they receive a text from our office asking them to rate their provider and the practice on a scale of 1 to 10 with the option to leave a short message. If a score is lower than we’d like, our patient care team follows up with them. This simple system has enabled us to make a bad situation right on multiple occasions and has undoubtedly saved us from letting unhappy patients walk out of our practice.

If you’re interested in learning more about our systems, you can find more information in this article from Modern Optometry.

QUOTE OF THE WEEK

“Things do not happen. They are made to happen.”

—John F. Kennedy