Regener-Eyes LLC announced the launch of preservative-free bottles with backflow prevention for two of its products: Regener-Eyes Professional Strength and Regener-Eyes LITE.
First up: a Regener-Eyes refresh.
The Regener-Eyes Ophthalmic Solution is marketed as being listed with the FDA and manufactured in a facility that’s both registered and inspected by the federal agency.
In general: Regener-Eyes is noted as:
- Intended for use as a lubricant to prevent further irritation or to relieve dryness of the eye
- Non-steroidal and preservative-free
And is intended to be used to:
- Provide temporary relief of burning and irritation due to eye dryness
- Provide temporary relief of discomfort due to minor eye irritations or exposure to wind or sun
- Use as a lubricant and protectant to prevent further irritation or to relieve eye dryness
Circling back to its regulatory status …
As we previously reported, Regener-Eyes filed an OTC Monograph Final for their flagship product, Regener-Eyes Ophthalmic Solution, in August 2022.
This OTC Monograph was the subject of the FDA’s final administrative order, translating to the non-prescription drug being “generally recognized as safe and effective (GRASE) for its intended use.”
- Editor’s note: See here for a look at Regener-Eyes’s recent encounters with the FDA.
However: In August 2024, the FDA sent a warning letter to Regener-Eyes, stating that Regener-Eyes PRO and LITE products are in violation of the Federal Food Drug & Cosmetic (FD&C) Act by being “unapproved new drugs introduced or delivered for introduction into interstate commerce (which is prohibited).”
- Take note: One of the issues outlined by the FDA in this warning letter concerned contamination risks—specifically the products were packed in multi-dose vials that do not have a mechanism for backup flow prevention and are preservative-free.
Now to these products.
Both Regener-Eyes PRO Strength and LITE are intended to be administered with one or two drops instilled into the affected eye(s), either as needed or by direction from an eyecare professional (ECP).
- Notably: Contact lenses are advised to be removed before administering either eye drop.
See here for details on their respective shelf lives.
And this recent launch?
The preservative-free bottles with backflow prevention are an upgrade from Regener-Eyes’ previous bottle design, which did not provide backflow prevention.
- As a refresh on the obvious: “Backflow prevention” involves the use of a device to stop water (or other fluid) from flowing in the wrong direction and, as a result, contaminating the solution.
For Regener-Eyes: These new ophthalmic multidose bottles with backflow prevention not only avoid the need for preservatives in the formulation but are also designed “to avoid bacterial contamination over treatment duration.”
- As a bonus: Via the use of PureFlow Technology, a one-way valve is also included on the bottles so no contaminated liquid is accidentally re-introduced into the bottle after a drop is administered.
Go on …
The distributor noted that the newly launched bottles were developed as a result of feedback from and consultation with physicians and industry experts across the United States.
- Per a company spokesperson: “We are committed to addressing that feedback and making the necessary changes to ensure the safety and efficacy of our products.”
- Plus: Following a discussion with the FDA last week, the company also expressed confidence in these new bottles meeting federal standards.
Definitely sounds like an improvement. But what will happen to the older bottles?
Good question.
The answer: Regener-Eyes also announced a voluntary recall of any remaining stock of its previous bottles, citing that “we believe this recall is the appropriate course of action for the company” to ensure patient and physician satisfaction and feedback.
So what should I do if I have these bottles?
Feel free to contact the company with any questions (including how to order these updated bottles) at either 877-206-0706 or via email at sales@regenereyes.com.