Terra Sigillata

I once had a pharmacology professor who told us, “Today’s side effects are tomorrow’s therapy.” What he meant was one’s garbage is another’s treasure. Side effects in one setting can be used for therapeutic benefit in another.

A perfect example is minoxidil, the antihypertensive vasodilator, that had the unusual side effect of causing inappropriate hair growth. But when formulated in a cream whose distribution could be restricted by where you put it, voila!…you have Rogaine (Regaine outside the US).

Well, a similar situation has been emerging over the last several years with “cosmeceuticals” meant to increase the appearance of eyelashes. Several brands are available but the most visibly promoted is RevitaLash, developed by a California ophthamologist who, as the story goes, wanted to help his wife who had lost her eyelashes to cancer chemotherapy.

The background on this “breakthrough” relates to the side effect profile of prostamides, drugs that treat glaucoma by reducing intraocular pressure. These compounds mimic the effect of prostaglandin PGF2α to promote outflow of aqueous humor from the eye through the trabecular meshwork by acting as a local hypotensive. In the US, there are two such drugs: bimatoprost (Lumigan®) and latanoprost (Xalatan®).

Where am I going with this? Well, deep within the prescribing information for Lumigan (PDF here) one finds:

Lumigan® may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Hmmm…a side effect. Might this be used for cosmetic purposes?


Enter RevitaLash®. The chemical formula of the active component in RevitaLash® appears to be 7-(3,5-dihydroxy-2-(3-hydroxy-4-(3-(trifluoromethyl)phenoxy)-1-butenyl)cyclopentyl)-
N-ethyl-(1R-(alpha(Z),2beta(1E,3R*),3alpha,5alpha))-5-heptenamide. I could use Molecule of the Day to help me with the structure, but let it suffice to say that this compound is quite similar to bimatoprost (the 3-(trifluoromethyl)phenoxy appears to be the biggest difference). So, this analog is probably acting similarly to the prostamides but is likely not covered in the patents by either drug company marketing prescription versions of their glaucoma drugs.

According to the RevitaLash® website, this is what the product does:

Like liquid eyeliner, RevitaLash® is simply applied once a day. Within three to ten weeks, your own natural eyelashes will look Longer, Thicker, Fuller, and BEAUTIFUL!

With that said, the question has arisen recently that this statement may constitute a claim that might be made for a drug.

But from their legal notices page, one finds:

Revitalash® Eye Conditioner is not intended to stop, prevent, cure, treat, relieve, alter, reverse or reduce eyelash loss or to promote the growth of eyelashes.

Well, that about covers it, huh? Totally clear, right? The disclaimer states the exact opposite of the claims made for the product on another page of the same website.

This leaves one to wonder: is the product intended to promote eyelash growth or not? It seems that the company wishes to have it both ways, perhaps to be as amorphous as possible to avoid any regulatory wranglings.

By the way, the product costs $149.95, plus shipping and handling.

At that price, you’d think they might be able to comp the shipping and handling.

Comments

  1. #1 elizabeth
    September 12, 2007

    My Revitalash contains N-ethyl-9a,11a,15s-trihydroxy-17-phenl-18,19,20-trinor-prost-5Z,13E-dien-1-amide. I didn’t see anything that said trifluromethyl. Of course the company refused to admit what the ingredient was for the first year I was told that the active is Bimatoprost, pure and simple. that is the glaucoma medicine what do you think of this

  2. #2 Abel Pharmboy
    September 13, 2007

    There may very well have been a change in formula since I last got my information. I’m very, very surprised that someone from the company would’ve told you it was bimatoprost itself. If the compound was indeed bimatoprost, the FDA would’ve stepped in an ordered them to stop using it. Therefore, I suspect that the active component is still a chemical analog of the glaucoma treatments.

  3. #3 Dr. Alan Bauman
    November 28, 2007

    You were ‘right on’ with your post in July. I’ve used Lumigan (bimatoprost) off label for cosmetic eyelash growth in addition to the Jan Marini, Revitalash and MD Lash Factor products for my patients who wanted a non-surgical alternative to eyelash transplants. Since the FDA raid, Revitalash has posted on their website that their formulation contains small amounts of bimatoprost and that they have halted dispensing the product. They also mention they are working on another formulation. MD Lash Factor also contains a prostaglandin F2 analog, but, according to Photomedix, it is NOT bimatoprost. MD Lash is also the only formulation with clinical trials for safety and efficacy. P.S. It also seems that the bimatoprost is working on the scalp… We’ll certainly keep an ‘eye’ on this.
    Sincerely,
    Dr. B.
    Alan J. Bauman, M.D.
    Medical Director
    Bauman Medical Group — Boca Raton, FL
    http://www.baumanmedical.com
    http://www.eyelash-transplant.com
    http://www.baumanblog.com

  4. #4 Kim
    December 26, 2008

    Oh man, I was just about ready to jump for this thing, medication or not, when I saw the price tag.

    I think I’ll stick with Maybelline. : )

    I don’t like to think of myself as a vain person, but man, to have some nice eyelashes would be REALLY nice…

  5. #5 Anne
    December 31, 2008

    So where does this leave those of us with alopecia and No lashes or scalp hair? Any hope?

  6. #6 tracy
    January 11, 2009

    My aunt used Lumigan for glaucoma & her eyelashes (they were nice beforehand) grew so thick, long & lush that they appeared fake! Since I don’t have glaucoma, I did not want to use the drug off-label for this side-effect & risk screwing up my eyes. Now that Latisse is on its way,I can’t wait to try it. Does anyone know whether or not the reformulated Revitalash & Nulash are as effective as the old formula & whether or not they’re safe? Revitalash makes no reference to the snafu they got into with Allergan & they refer to their new formula as ‘new & improved’. Is it?

  7. #7 kay
    February 19, 2009

    Latisse has been out for a few weeks now . . . any one with results?

  8. #8 maureen
    February 24, 2009

    Tracy, I was wondering if your aunt had any darkening in the colored part of her eyes; a possible side effect with Latisse. I bought the product today and I am scared to use it as I have light brown eyes and don’t want them to turn dark.

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