Regener-Eyes Tonicity Solution Sodium Chloride
Secret Sauce, or Secret Salt
It’s a bright shiny 2024, and Regenerative Processing Plant / Regener-Eyes LLC et al (hereinafter ‘Regener-Eyes’) has driven me to new heights of aggravation with its marketing pivot towards the Veterans Health Administration, the Department of Defense, and that perennial “save a buck to spend $10” shopper, Kaiser Permanente.
Rebecca has a fresh blog post titled “How much is a glycerin eye drop worth?” According to her stats, Regener-Eyes PRO and LITE are the most expensive OTC glycerin eye drops, on a per cc basis, ever.
Regener-Eyes has told the FDA that the active ingredient for both PRO and LITE is glycerin. It has also told the FDA – in the formal product ingredient table – that the inactive ingredients are water and sodium chloride. Both formulations are registered as OTC drugs. Nothing special, move along.
Sit down people, stop waving your hands, I am going there next.
Part 1: The Secret Protein Sauce – d-MAPPS™
In the glory days of 2021 and 2022, Regener-Eyes was advertising the smack out of all the chemokines, cytokines, growth factors and other sensual immunomodulators in their First in Class! Biologic! eye drops. It called this secret sauce d-MAPPS, which stands for “derived multiple allogeneic proteins paracrine signaling.” Regener-Eyes couldn’t list d-MAPPS as any type of ingredient in the official FDA ingredient table because – surprise! - nobody else has any idea what d-MAPPS is, so it doesn’t have a Unique Ingredient Identifier (UNII). No UNII, no listee.
But Regener-Eyes could put d-MAPPS on the box. You can put any kind of shit you want on an OTC box. I know. I listed Mermaid Tears, and it has the words carbonation, aquarium and ‘may affect your genome’ on the box. Check it out on DailyMed.
And Regener-Eyes could talk about this secret protein sauce to ECPs and make itself look all Biologic Boutique Pharma by charging crazy prices for 3 cc bottles. These OTC eye drops were so special that patients had to have permission from their ECPs to buy them.
October 5, 2022. What no ScamPharma® manufacturer wants, ever: a letter from the FDA in an overnight envelope.
You see, to the FDA “protein” is a fightin' word. You can’t put proteins in your eye drops and register and sell them OTC. There is nothing new or unfair about the Federal regulations that define drug products containing proteins as biologic drugs. But many ‘regenerative medicine’ manufacturers – including Regener-Eyes – were pretending that their products were regulated as human tissues rather than as human drugs. In June 2021, the FDA started cracking down on this behavior.
So now you’re Regener-Eyes and you’re having an Oh Shit moment. Your drops are drugs not tissues, you advertise that they contain proteins, and your tiny company has come to the unfavorable attention of the Food & Drug Administration. The FDA nastygram was certainly the fault of Rebecca at the Dry Eye Foundation and her long-time crony DrB. [Ordinary people who persuade lawyers at the FDA to read their emails, who does that?] Those hags are undoubtedly stalking your web page, so a soothing reply letter to the Federales apologizing for the mistakes and promising to do better – eventually – won't buy you much time. Thus d-MAPPS has to go, as does any mention of proteins or the immune system.
Part 2: The Secret Salt
I give plenty of credit to Regener-Eyes for creative obfuscation, plus sticking with what works.
Regener-Eyes simply swapped out d-MAPPS for Tonicity Solution™, and then in short order swapped again to Tonicity Solution Sodium Chloride* (no TM). No one knows what this ingredient is either. No UNII, no listee, but it’s on the box. The price is the same – which is to say, insanely high for a glycerin eye drop – so the product must be just as First in Class! (shhhh...biologic) as the Original Regener-Eyes.
Unlike d-MAPPS, the name Tonicity Solution Sodium Chloride doesn’t provide any idea as to what the ingredient is or contains beyond sodium chloride. It implies what the ingredient does, which is to affect the tonicity of something: presumably the tear film, hopefully in the right direction.
Also, a solution is a liquid, so TSSC isn’t a solid. This might seem obvious, but since water is listed as a separate ingredient, technically TSSC cannot contain water because then water is effectively listed twice which is a formula no-no. If TSSC is a solution of “magic” dissolved in water, then “magic” should be listed as the (inactive, but not really) ingredient. But I regress into my former life as a Chemistry major at UC Berkeley (Class of 86).
There are clues to the identity of Tonicity Solution Sodium Chloride in my current all-time favorite FDA document, the Regenerative Processing Plant inspection report Form 483.
Form 483 from the June 2023 inspection states that the current products are the (with glycerin)** formulations.
Form 483 also states that according to Regener-Eyes, the company stopped manufacturing amniotic fluid eye drops in June 2021. Therefore, I deduce that (with glycerin) means (instead of with amniotic fluid).
Form 483 Observation 10 busts Regener-Eyes for failing to confirm the identity of its bulk ingredients, which in this case are glycerin, sterile water, and Tonicity Solution Sodium Chloride. Oh, how I long for the un-redacted version of the report (FOIA request still hanging fire). But we can puzzle this through.
First, Regener-Eyes says that its magic is not amniotic fluid anymore. But it needs providers and patients to believe (without saying so on the internet) that the protein magic still exists. Where could it come from? Remember that “placental based bio-materials" phrase that was around for a while? Also #placenta? So maybe Tonicity Solution Sodium Chloride is a combination of processed placenta and salt, in a liquid form (ick).
At $199 for 3 cc, no way is Tonicity Solution Sodium Chloride just salt water! The price is the proof!
Let’s think for one hot minute about where you could find a drug bulk ingredient supplier who would manufacture and sell a substance derived from placenta (hopefully human, but who knows, no one is checking) and table salt, dissolved in a liquid. I know this is Florida, but still.
The FDA didn’t complain specifically about any ingredient except the (redacted adjective) sodium chloride. If there was placenta extract in Tonicity Solution, I truly believe Form 483 would be shitting an even bigger regulatory brick than it already does. FDA inspections in the US are unannounced, so no one at Regener-Eyes had time to stash or trash anything like frozen placentas. [If they had, they might have removed those untested media tubes from the refrigerator.]
Part 3: What’s regenerative about glycerin or salt?
Let’s do a bullet re-cap:
Regener-Eyes told the FDA in June 2023 that it stopped putting amniotic fluid in its eye drops in June 2021. This is precisely the month and year that the FDA began enforcing regulations applicable to commercial drug products containing ingredients derived from human tissues or fluids.
So, Regener-Eyes knows the rules.
It is implausible that Regener-Eyes would fall into line on the amniotic fluid ban yet believe that the FDA would be okey-dokey with a protein cocktail derived from donated placentas.
Obtaining and processing placentas to extract proteins is vastly messier and more time-, equipment- and cost-intensive than diluting and filtering amniotic fluid.
The FDA didn’t document finding placentas or placenta juice during its unannounced inspection of Regener-Eyes' manufacturing facility in Palm Harbor, Florida.
Ergo, possibly d-MAPPS was always marketing hype, and after June 2021 there were no proteins in Regener-Eyes PRO or LITE at all.
Available evidence from the FDA inspection report – even with redactions – suggests that Tonicity Solution Sodium Chloride is saline solution.
Regener-Eyes has perpetuated the idea of regenerative magic from its secret protein sauce by keeping the price extremely high, whispering in the ears of providers at national meetings, and using Key Opinion Leaders to sustain the protein belief system.
The cytokines, chemokines and growth factors must still be in there, otherwise why would anyone pay $199 for 3 cc of 0.5% glycerin?
If you illegally market an unapproved biologic drug, but it’s not really an unapproved biologic drug, who’s in charge of that?
—
*This is in the free-text ingredient data field, not the official ingredient list. The official ingredient list is “No UNII, No Listee, No Putee in Product.”
**The parentheses are in the report.
+The earliest documents authored by C. Randall Harrell MD that use the acronym d-MAPPS describe it as derived from amniotic fluid.