We’ve already got a cure for a problem most of us didn’t know existed: short eyelashes. On December 5, a panel of independent eye and skin experts convened by the FDA voted unanimously that the benefits of the drug Lumigan (bitamoprost), making lashes longer and fuller, outweigh the risks. The drug’s maker, Allergan, may soon be able to add this as a companion to its blockbuster cosmetic drug Botox. Allergan plans to re-introduce the drug under the name Latrisse, and claims that the market for it could eventually reach $500 million. Allergan stock rose 3.7% in the wake of the announcement.
Allergan did not set out to find a drug that promotes eyelash growth. The effect of Lumigan on eyelash growth was a serendipitous discovery. Lumigan was brought to market as a treatment for glaucoma, one of the leading causes of blindness worldwide. Lumigan belongs to a class of drugs known as prostaglandin F2α analogues. When given as eye drops, they act to reduce the elevated pressure inside the eye caused by glaucoma. Lumigan is among the most effective medications in the class.
After Lumigan went into widespread use, side effects were observed. These were particularly remarkable in patients who needed glaucoma treatment in only one eye. It became obvious that Lumigan cause increased pigmentation in the iris, and led to excess eyelash growth, making eyelashes on the affected side noticeably longer and fuller. The use of Lumigan seems to be quite safe, as well. According to The side effects of prostaglandin analogues, in the January 2007 issue of Expert Opinion on Drug Safety:
In the last decade topically applied prostaglandin F2α analogues … have become widely used as a means to reduce elevated intraocular pressure in patients with glaucoma and ocular hypertension… [T]he systemic side-effect profile is favourable for all the prostaglandin analogues, and some of the local side effects are only of cosmetic significance. Numerous clinical studies suggest that discontinuing treatment with prostaglandin analogues on account of their side effects is rare in clinical practice.
That was all it took. As soon as this side effect was recognized, dermatologists began prescribing it “off label” for eyelash enhancement.
Once a drug is approved by the FDA for one use, it can be prescribed by any physician for any use. That’s known as “off label” prescribing, and is sanctioned by the FDA. Google “Lumigan eyelashes” and you will find hundreds of entries as well as multiple Google Ads. Allergan did not have to seek approval from the FDA for the use of Lumigan, because it already has FDA approval for use in glaucoma. However, the FDA specifically prohibits a drug company from marketing a drug for an off-label use. Allergan wants to exploit the market for cosmetic Lumigan with an advertising campaign similar to its wildly successful campaign for Botox. That is why it is willing to do the additional work and submit the additional data needed for approval as a cosmetic agent.
Lumigan represents a bonanza for Allergan. All of the development work and most of the testing have already been done. It is already a successful product, and by rebranding is as Latrisse, the market can be dramatically increased. Best of all, the eyelash effects of Lumigan are only temporary. Unless it is applied once a day (with a mascara wand), the effect wears off. There’s nothing better for a drug company than a product that must be used every day.
Are there any ethical objections to bringing a drug to market for the sole purpose of promoting eyelash growth? In effect, it is too late to ask that question. The FDA has approved Lumigan for medical use, and it can be and is being prescribed for cosmetic use already. Asking the FDA for cosmetic approval commits Allergan to conducting additional studies on the effect of using Lumigan for purely cosmetic reasons, which will ultimately provide consumers with more information on risks and benefits.
Most importantly, we can rest soundly, knowing that no one will need to suffer from the heartbreak of short eyelashes anymore.