IRVINE, CALIF. — A new prescription product that promotes eyelash growth (Latisse, bimatoprost ophthalmic solution 0.03 percent; Allergan) will benefit cosmetic-minded patients and the physicians who serve them, sources say.

Among oculoplasts, however, there is concern about some of the drug’s side effects. In addition, some oculoplasts say more research needs to be done before they’d feel totally confident in non-eye specialists monitoring the drug’s use without, in some cases, seeking consult with an oculoplast.

In late December, the FDA approved Latisse for treating eyelash hypotrichosis. Bimatoprost (Lumigan, Allergan) first earned FDA approval in 2001 for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension, said Frederick Beddingfield, M.D., Allergan’s chief medical officer and vice president of dermatology research and development, at a Jan. 27 press conference.

Allergan has known that bimatoprost’s side effects include eyelash growth, “but we didn’t embark on this process of having it approved for aesthetic use until we had years of safety data,” he said.

In a phase 3 study, investigators enrolled 278 adults with minimal or moderate eyelash prominence, randomizing them to apply Latisse or a placebo to both upper eyelid margins once nightly for 16 weeks.

Based on investigator assessments, “More than 78 percent of patients in the Latisse group — compared with slightly more than 18 percent in the placebo group — experienced at least a one-grade increase in overall eyelash prominence at the end of the treatment period,” said Steven Fagien, M.D., a Boca Raton, Fla., aesthetic oculoplastic surgeon and study investigator, at the press conference.

Additionally, Latisse achieved more than 100 percent mean improvement over baseline for eyelash thickness. Patients tolerated Latisse well, he added.

However, Dr. Fagien said, “It’s important for patients to understand that they may experience redness for the first few days and maybe weeks of treatment. But in the majority of cases, over time, the redness decreases or disappears.”

Patients also must understand that applying more bimatoprost than prescribed won’t necessarily boost efficacy, Dr. Fagien said, though doing so may increase incidence of unwanted side effects such as lid-margin irritation.

Dr. Fagien added that although Latisse’s label warns of possible changes in iris pigmentation, he said investigators observed no such changes.

The Unknowns
Stuart R. Seiff, M.D., emeritus professor of ophthalmology at the University of California, San Francisco and the 2009 president of the American Society of Ophthalmic Plastic and Reconstructive Surgery, says the pigmentation-change side effect concerns him, as does the fact that the Latisse trials covered use only on the upper eye lashes.

“I served as one of the ophthalmic examining centers for the Latisse study, and I should point out that, to my understanding, this study was to determine efficacy — not safety — for lash growth in patients with thin lashes,” he tells Cosmetic Surgery Times. “Although not found in the study, I still feel that patients with light irises run the risk of increased iris pigmentation and eye-color change — they should be cautioned in this regard as part of informed consent. In the study, patients only put the medication on the upper lashes, trying to limit ocular exposure. Use on the lower lashes is off label, but we are sure patients are going to do it — and the effects of this application are unknown.

“Given the limited problems encountered in the study patients, however, I think it is reasonable for non-ophthalmologists to prescribe Latisse to their patients, with the previously mentioned cautions.”

Robert A. Goldberg, M.D., chief of orbital and ophthalmic plastic surgery at the Jules Stein Eye Institute in Los Angeles, shares Dr. Steiff’s concern about the potential pigmentation-change side effect and his belief that more trials are needed on the drug.

“Perhaps the biggest risk is changing the color of the iris, particularly light brown becoming darker,” he says. “It is not clear if this is reversible — it may be a permanent change or at least very long-lasting. I don’t think we have enough data to really know how often this will occur when the medication is applied to the eyelashes.”

Dr. Goldberg says that if a significant amount of Latisse gets in the eye, it could have other, more serious side effects. “I am not sure how to assess that risk,” he says. “I did not read the preliminary Allergan studies so I don’t know how they determined what amount of medication leaches or leaks onto the ocular surface. I trust Allergan that the initial studies were done well. It makes sense that if the medication stays on the eyelashes and does not get in the eye significantly, then ocular side effects will be rare.

“There are always unknowns with a new application like this, and some variability depending on how well patients follow the instructions,’ he adds. “Careful analysis of a large group of treated patients over time will be the only way to really know the incidence of side effects. I am optimistic that long-term follow-up will support the initial studies, with a low rate of ocular complications.”

Allen Putterman, M.D., professor of ophthalmology and co-chief of oculoplastic surgery at the University of Illinois College of Medicine, says he feels confident in Allergan’s Latisse trials — so confident that he’s already prescribed the drug for some patients and staff, and even his wife.

Dr. Putterman also feels confident that non-eye cosmetic physicians are perfectly capable of monitoring the effects of the drug once it’s administered — though within certain parameters.

“If the physician uses loupes or a magnifying glass, they should be able to note eyelash growth, as well as the possible complications of eyelid-skin pigmentation, swelling and redness; changes in the color of the iris, and ocular redness. They should also be able to monitor changes in vision by using a reading card, and lastly, they should be able to detect any unusual symptomotology by taking a careful history — this should take care of the majority of monitoring issues,” he says. “However, the product can also lower the intraocular pressure if a moderate amount gets into the eye, and this can only be measured by checking the intraocular tension with instruments such as a tonometer, and most non-ophthalmologists will not be comfortable doing this test.”

Even if there is a decrease in intraocular tension, there is minimal chance that it will affect the health of the eye, Dr. Putterman says. “A rare side effect of the product is inflammation,” he says. “If the patient has a red, painful eye, I recommend that that patient be referred to an ophthalmologist to rule out inflammation.”

Dr. Steiff says he would like to see further trials looking at the drug’s use on the lower lids, long-term use in patients with light irises, and how often the drug must be used each week after the first two months to keep new lashes in place.

Further testing also can determine the extent to which eye specialists should be involved in the monitoring of Latisse for cosmetic use — or whether they should be at all, says Dr. Goldberg.

“Only by knowing the true incidence of ophthalmic complications can we give advice whether all patients should be treated, or followed, by ophthalmic specialists,” he says. “If, as we hope, the incidence is extremely rare, then I think an argument could be made that any physician could dispense the medication, and that is apparently Allergan’s stance.”