It's hardly unusual for a pharmaceutical product to find a market other than the one for which it was envisioned. Such is the case with Latisse, and besides its benefit to patients, its serendipitous arrival in uncertain economic times may be a boon for physicians.
"We're all looking at ways to increase our bottom line or economic margin during down times, and ophthalmologists can easily incorporate the distribution of Latisse into their offices. They are already well familiar with Lumigan's effectiveness and side effects," says Karl G. Stonecipher, MD, who is director of the
Latisse and Lumigan are the same formulation (bimatoprost ophthalmic solution 0.03%) applied in different ways. Latisse, which was recently approved by the Food and Drug Administration, is applied once daily to the base of the upper eyelashes with a single-use per eye disposable applicator and is only available with a prescription. Patients can expect to see longer, fuller and darker lashes in eight weeks, with full results occurring within 16 weeks. "It is similar to simply applying eyeliner to the eyelid margins," explains Steve Yoelin, MD, who participated in the clinical trials of Latisse.
To maintain the effect, continued treatment with Latisse is required. If patients stop using Latisse, their lashes will return to their pre-treatment state within a few weeks or months.
Although Lumigan is the same formulation, patients should not use it to grow their lashes because Lumigan is applied to the ocular surface. "Lumigan can cause hyperpigmentation of the eyelid margins and it can cause a light-colored (blue or green) iris to turn darker," Dr. Stonecipher says. Additionally, ophthalmologists should not prescribe Lumigan for lash growth because it is not FDA approved for that indication.
Efficacy and Safety
The Phase III study assessing the effectiveness and safety of Latisse included 278 healthy adults with no active ocular disease and with minimal or moderate eyelash prominence at baseline. In this study, 137 patients were randomized to apply Latisse and 141 patients were randomized to apply vehicle to both upper eyelid margins once daily for 16 weeks. The primary efficacy endpoint was overall eyelash prominence at the end of the 16-week treatment period as measured by at least a 1-grade improvement on a 4-point Global Eyelash Assessment Scale.
After one week of treatment, seven (5 percent) patients in the Latisse group and three (2 percent) patients in the vehicle group achieved a 1-grade increase from baseline on the Global Eyelash Assessment Scale. After eight weeks of treatment, 69 (50 percent) patients in the Latisse group and 21 (15 percent) patients in the vehicle group achieved a 1-grade increase. After 16 weeks of treatment, 107 (78 percent) patients in the Latisse group and 26 (18 percent) patients in the vehicle group achieved a 1-grade increase.
Secondary efficacy endpoints were eyelash length, thickness and darkness as determined by Digital Image Analysis of patient photographs. Improvements were significantly more pronounced in the patients applying Latisse at weeks eight, 12 and 16.
At week 16, patients in the Latisse group achieved a 25-percent increase in eyelash growth (1.4 mm) compared to a 2-percent increase in eyelash growth in the vehicle patients. Patients in the Latisse group also achieved a 106-percent increase in fullness/thickness compared to a 12-percent increase in the vehicle patients.
Additionally, patients in the Latisse group achieved an 18-percent increase in the darkness of their lashes compared to 3 percent in the vehicle group.
Latisse was also well-tolerated with the most commonly reported adverse events being non-serious and cosmetic in nature. The most commonly reported adverse events were eye pruritis, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry-eye symptoms and erythema of the eyelid. These were observed in less than 4 percent of patients.
Dr. Yoelin conducted the initial study to investigate the safety, efficacy and subjective experience of patients using Latisse for the treatment of hypotrichosis. Study results were recently presented at the annual meeting of the American Society for Cataract and Refractive Surgery. This prospective, open-label, proof-of-concept study included 28 women with an average age of 49 years (range: 32 to 73 years). At week 12, 16 patients reported a change in eyelashes from baseline. Of these 16 women, three had improved eyelashes and 13 had much improved eyelashes.
Additionally, 15 (94 percent) patients "much" or "very much" agreed that Latisse was helpful and 12 (75 percent) "much" or "very much" agreed that they had done something positive for their appearance. All patients said they felt more attractive at the end of the treatment period.
No serious adverse events were reported. Slight skin darkening in the general application area was noted in five patients.
Marketing Latisse
Dr. Stonecipher has both a refractive practice and a cosmetic practice. "In our cosmetic practice, we were familiar with products that were available to help with lashes and loss of lashes. Once we heard of Allergan's promotion of Latisse and its ultimate approval, we started marketing it directly to our patients through brochures and pamphlets in the waiting room. We got a pretty significant response from that. Then, we did a couple of radio ads over the course of a month and got a large response," he says.
He believes that internal marketing and patient word-of-mouth are the best marketing tools and that external marketing does not need to be extravagant. Dr. Yoelin also believes that word-of-mouth marketing is effective. "Latisse has created a new source of patients for my practice. These patients as well as their friends and family have all become very important to my ophthalmology office. Latisse is extremely important to my practice in general and to the aesthetics portion of my practice in particular," he says.
Dr. Yoelin, who is in private practice in Newport Beach, Calif., devotes three days a week to using facial injectable products, so many of the patients who come to his office for cosmetic purposes are already familiar with Latisse and what it can do for their lashes.
"Patients who are using the product will tell their friends about their more prominent lashes and their friends will come in and purchase Latisse. These 'new' patients are subsequently introduced to our practice in general and our injectables practice in particular. This scenario is quite common, and it has helped me to grow my aesthetic practice. Given the fact that Latisse is a new product, many of my patients are not familiar with this particular medication. If this happens to be the case, I often will simply ask them if they would like longer, darker and thicker eyelashes. It seems as if the vast majority of my female patients would like more prominent eyelashes," he says.
If ophthalmologists are interested in adding aesthetic injectables to their practices, Dr. Yoelin notes that Latisse can function as a "gateway" medication for these ophthalmologists.
Dr. Stonecipher notes that, in addition to purely cosmetic indications, it also can be used for therapeutic purposes. Latisse works well on patients who have lost their lashes due to age or chemotherapy.
Dr. Yoelin agrees. "Numerous patients suffer from short or inadequate eyelashes.
Additionally, certain medical conditions and medications will lead to profound loss of or reduction in eyelashes. In some cases, patients can find the loss of their eyelashes to be quite debilitating, and it can serve as an acute source of embarrassment. I have found that Latisse offers a therapeutic benefit as well as a cosmetic benefit to my patient population," he adds.
According to Dr. Yoelin, the response from his patients has been extremely positive.
"Interestingly, I believe that some of my happiest patients are those individuals who lost their eyelashes secondary to a medical condition or as a result of using a particular medication. For example, in my investigator-initiated trial using bimatoprost, one patient in particular lost her eyelashes due to a medical condition. The eyelashes that she grew as a result of the treatment protocol allowed her to leave her home and go out in public without having to routinely worry about gluing on fake eyelashes," he says.
Cost
According to Dr. Stonecipher, Latisse costs $75, and ophthalmologists are charging on average $150 for a one-month supply. "Latisse is going to bring in revenue from patients who are already in your office. Patients can be shown DVDs or given pamphlets while they're sitting in the room dilating or waiting for the doctor. This is just another way to add to the bottom line in our practice without too much added cost or effort," he explains.
