Terra Sigillata

i-f195674cafb84a1828660e701e3de03e-twitter.jpgThe tagline is from Elaine D’Farley at Self magazine talking about the FDA’s then-pending approval of Allergan’s Latisse™ for cosmetic growth of longer, thicker eyelashes treatment of hypotrichosis of the eyelashes. While not expected until early 2009, Jacob Goldstein at the WSJ Health Blog clued me in to the approval last Friday (Allergan press release here).

Whether Ms. D’Farley intended, the choice of the brandname, Latisse, conjures up images of the design of the same name used on handbags and area rugs.

Allergan is a leader in “medical aesthetic products” such as botulinum toxin type A for injection (BOTOX® Cosmetic) to lessen wrinkles of the skin. Interestingly, Botox is also tremendously valuable drug to people with chronic migraines but the cosmetic status of the drug often makes it difficult to obtain insurance reimbursement for this therapeutic indication.

The backstory here, however, is one that casts pharmaceutical companies in a bad light and feeds conspiratory thinkers that the FDA is “in bed” with Big Pharma.


The active component of Latisse™ is bimatoprost, the very same prostamide present in Allergan’s Lumigan® product, approved for the treatment of open-angle glaucoma or ocular hypertension. Pfizer sells a similar product, Xalatan®, the brand name for latanoprost. 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.

We first spoke of bimatoprost back in July 2007 as an example where a side effect observed for one therapeutic indication might have even greater value in another setting. I later used this case to invoke my legendary pharmacology professor, Dr G Victor Rossi, for teaching me in 1983 that “today’s side effects are tomorrow’s therapy.”

The interesting twist was that because Allergan could not actively promote Lumigan for cosmetic purposes, cosmetics companies began selling knock-off compounds to the mascara market. The best known of these was RevitaLash from Athena Cosmetics and Age Intervention Eyelash Conditioner from Jan Marini. (Nevertheless, a physician commenter on our blog noted they were already prescribing Lumigan for cosmetic purposes and treatment of eyelash loss following cancer chemotherapy.). These products sell/sold for about $150 USD, plus shipping and handling, for a one month supply.

However, Revitalash and all cosmetics are regulated by the US FDA under the Food, Drug, and Cosmetic Act of 1938 (and subsequent legislation). Recall that companies in the US may sell dietary and other health supplements without safety or efficacy assessment as long as they do not make direct disease-treatment claims on the label. But what about cosmetics that have the potential for a pharmacological effect?

Well, the FDA raided Jan Marini’s San Jose, CA, warehouse in November 2007 and seized thousands of tubes of Age Intervention Eyelash Conditioner under the claim that the product represented an “unapproved and misbranded” drug. According to Rhonda Rundle in the Wall Street Journal:

The agency said it hadn’t received any reports of patient injuries, but warned the product might be potentially harmful because it contains bimatoprost, the Lumigan ingredient.

My examination of the RevitaLash label was suggestive that it contained some analog of bimatoprost or latanoprost (and continues to be sold), but FDA deemed that the Jan Marini folks were selling the exact same molecule as that patented by Allergan. Allergan also already had clinical trials underway for cosmetic growth of longer, thicker eyelashes treatment of hypotrichosis of the eyelashes. With a unanimous (9-0) recommendation on 5 December by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee, FDA approved Latisse-brand bimatoprost 0.03% ophthalmic solution with a mascara-like applicator while Lumigan-band bimatoprost 0.03% ophthalmic solution as eyedrops will remain on the market for glaucoma.

Several interpretations of this story are possible:

1. Allergan had FDA in their pocket to shut down Jan Marini and protect the company’s market position with bimatoprost until eyelash clinical trials could be completed.

2. Jan Marini was guilty of patent infringement and benefited for months or years by selling a cosmetic product for $150/month that was not manufactured under strict guidelines. Consumers Patients will now have safe access to a controlled pharmaceutical product to improve eyelash thickness and density.

3. Allergan played by the rules and took advantage of a time-tested strategy in the pharmaceutical business model: finding a new indication for an already-approved product and now deserving of the return-on-investment for conducting clinical trials for use in a rare disease that just happens to have overlapping cosmetic application in the $3.7 billion/year mascara industry (Allergan estimates that global peak sales of Latisse will be $500 million/year.). Moreover, by securing approval under a different brand name than Lumigan, Allergan will also enjoy extended patent life. Allergan shareholders (and those of you who may not realize some of your 401(k) or 403(b) funds have a position in Allergan) should be pleased.

Allergan suggests that Latisse will retail for approximately $120 for a month’s supply. While not likely to be covered by insurance (as Lumigan is on many plans), this price is somewhat of a discount relative to similar products by cosmeceutical companies. I’ll have to compare Lumigan and Latisse pricing side-by-each but there are plenty of places out there selling the existing drops that docs have been prescribing with a mascara applicator.

As a pharmacologist, I’m torn. I’m not crazy about cosmetic uses of drug molecules but, then again, I am a white male who is not under external pressure to look a certain way. In fact, I do believe that there are some synthetic retinoids laying about the house being used by other inhabitants for cosmetic purposes and it has been suggested to me more than once that I try it for my wrinkles (and that inhabitant’s stylist has suggested previously that I might care to color the grey in my goatee to enhance my aging hipster cred).

But if people are going to use drug molecules for such a purpose, I come down on the side that they be used as safely as possible and that the formulations be manufactured under stringent guidelines.

Nevertheless, I can’t exactly blame the anti-FDA, anti-Big Pharma conspiracy mongers for thinking the parties could’ve put a better face on this episode.

For your easy reference, here are all Terra Sigillata posts by Abel Pharmboy on eyelash cosmeceuticals:

27 July 2007: For thicker, fuller lashes…a glaucoma treatment
20 November 2007: Forty lashes for a cosmeceutical company
7 January 2008: Jan Marini finally bats an eye at FDA, Allergan
4 June 2008: Today’s side effects are tomorrow’s therapy
28 December 2008: Latisse™: eyelashes are the new handbag

Comments

  1. #1 MattK
    December 28, 2008

    Interesting. So cosmetic companies can sell drugs as long as they don’t claim a medical effect?

    Interestingly, Botox is also tremendously valuable drug to people with chronic migraines but the cosmetic status of the drug often makes it difficult to obtain insurance reimbursement for this therapeutic indication.

    BOTOX can also be used in physiotherapy to temporarily weaken or paralyze certain muscles that have overcompensated for others. This can give the other muscle groups a chance to develop. I know someone who had this treatment to correct foot and leg problems that developed after a stroke. As far as I know there was no problem with medicare but then, this is Canada.

  2. #2 drug ratings
    December 29, 2008

    I agree. It is a tough decision.

  3. #3 Dr A
    December 31, 2008

    Oh dear.

  4. #4 sanjiva
    January 3, 2009

    The FDA did what it had to – Allergan holds the patent for the molecule, and was the one that paid for the initial clinical trials on Lumigan in the first place. I think the system should fairly reward companies that invest in their own R&D. I think there should be a level playing field.

    Some people may say it’s a pretty frivolous indication, but I’m not so sure. I don’t think it’s necessarily vanity, because some people are in a line of work where appearance matters.

  5. #5 latisse
    August 28, 2009

    I’ve heard good things about latisse lately and Latisse ads are all over the magazines and internet.
    “Allergan suggests that Latisse will retail for approximately $120 for a month’s supply.” – well yes and no, because after 16 initial weeks you can use 2-3 drops a week to maintain it.

  6. #6 Eyelash grower
    October 5, 2009

    After hearing that there are few side effects from Latisse, I going to stick with Lilash, which I looooove

  7. #7 fade watches
    July 30, 2010

    hearing that there is few side effects from Latisse, I going to stick with Lilash, which I looooove

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