Dana Gaiser, a 27-year-old bride-to-be, said thin eyebrows, perhaps caused by too much teenage plucking, have often troubled her. After seeing an ad for Latisse, which grows fuller eyelashes, Dana asked her doctor about her options. While he originally tried to steer her toward more first-step options for hair growth, Dana persisted and her doctor gave her the Latisse prescription.

When applied to upper eyelashes regularly, Latisse prolongs the lash growth phase resulting in longer, fuller-looking lashes. Six weeks after Dana started applying Latisse to her eyebrows, she began seeing growth in previously sparse areas.

“People say eyebrows frame a face, and I really believe that now,” Dana said. “To be able to actually shape them and make them look the way I want, it’s a huge deal.”

These positive results may, in part, be what is spurring Allergan, the manufacturer of Latisse to test its effectiveness in treating brow and scalp hair loss.

If the testing proves successful, Allergan is hoping these current off-label uses for Latisse will gain FDA approval by 2013, according to a company spokeswoman.

According to hair restoration specialist Dr. Alan Bauman, Latisse has already been used off-label by some patients and produced “modest hair growth” along the scalp.

Given Latisse’s overwhelming success in promoting eyelash growth and the product label’s warning that it can cause hair growth on other parts of the body that come in contact with the drug, it’s no surprise that Allergan created a product purposed to do just that.

Information on the FDA Clinical Trials website indicates that the Phase One trials for the hair-growth drug will focus on testing safety of two formulations of bimatoprost, the same active ingredient found in Latisse at only a 0.03% dosage.

Dr. Bauman suggested that Allergan’s new hair loss treatment will likely use a higher concentration of bimatoprost, however the exact amounts contained in the drug being tested are not yet known.

Phase One trials are designed only to test the safety of the drug, so consumers will have to wait until Phase Two and Phase Three of testing are complete before any proven indication of the effectiveness of the hair loss treatment are known. But if the effectiveness of Latisse for eyelash growth is any indication, a higher concentration of bimatoprost is likely to stimulate hair growth on the scalp.

A new treatment for baldness would be a welcome advancement for the estimated 60-100 million Americans suffering from alopecia or thinning hair, as only a handful of other drugs have been approved for hair restoration.

“…bimatoprost could become the third FDA-approved drug for the treatment of baldness in men and only the second FDA-approved drug for women with hereditary hair thinning or female pattern baldness,” according to Dr. Bauman.

Allergan argues that because their company has marketing exclusivity for Latisse until late 2011 and is further protected by patents that expire as far out as mid-2024, Apotex had no business filing an application with the FDA seeking approval to make and sell generic Latisse.

On the other side of the argument, Apotex maintains that while two Latisse-related patents are valid and enforceable, the third patent is irrelevant and would not prevent Apotex from forging ahead with a Latisse knock-off.  Apotex also alleges to have sent Allergan a letter in July 2010 explaining the company’s stance.

After Latisse launched its massive advertising campaign featuring Brooke Shields and now, Claire Danes, it didn’t take long for consumers to figure out that instead of using one Latisse applicator per upper eyelid each day as directed, they could get double the treatments (and spend half the money) by using one Latisse applicator on both upper eyelids each day.

Considering consumers’ conservative use of Latisse and the resulting lower-than-expected sales figures, Allergan’s move to protect its eyelash enhancement market share by suing Apotex over its plans to promote a Latisse copycat is no surprise.

In June 2010, Allergan lowered its full-year Latisse sales forecast to a range of $90 million to $100 million, down from a prior $140 million goal. A $40 million to $50 million profit decrease may not seem like much for a company that pulled in over $4.5 billion last year, $600 million of which was generated by Botox sales, but Allergan stands to lose twice as much if a generic Latisse product catches on.

What doctors labeled a ‘complication’ or side effect of using these topical agents was “hypertrichosis,” a condition characterized by darkening, thickening, and lengthening of the eyelashes.

Allergan offered the topical prostaglandin Lumigan in 2001, a drug that contained the active ingredient bimatoprost. Two important precursors to Latisse occurred after the FDA gave clearance for Lumigan.

Jan Marini Skin Research Inc had over $2 million worth of product seized by the Food and Drug Administration.  The product, Age Intervention Eyelash, evidently contained bimatoprost, which was unapproved for cosmetic use at the time. Allergan later filed a patent infringement suit against Jan Marini and several other companies that had tried to market bimatoprost in their eyelash enhancing drugs.

Some doctors started prescribing Lumigan off-label to enhance eyelashes.  Knowing the desirable side effects it could produce. But Lumigan wasn’t formulated for cosmetic use and many believed more research was needed to confirm the safety of topical prostaglandins for cosmetic use.

Clinical trials and further research is exactly what Alllergan Inc did.  In one early study, 278 healthy adults with minimal to moderate eyelash prominence applied bimatoprost or a placebo to their lash line.  The results were favorable; researchers observed that the average patient’s eyelashes were 25 percent longer, 106 percent fuller, and 18 percent darker, while only 3.6 percent experienced itchy eyes and redness, and only 2.9 percent experienced skin hyperpigmentation.

Latisse received FDA approval late last year for the treatment of ‘inadequate’ eyelashes.  Allergan now owns the patent on use of bimatoprost for eyelash enhancement.

Contact our office for more information on Latisse in Kentucky.