A patient was seen in our practice recently for hypotrichosis. She had asked for Latisse(brimatoprost 0.03%, Allergan) but was turned down by previous ophthalmolgoist. We in turn had the same opinion, as she had severe blepharitis, which resulted in thin brittle lashes that were in different stages of growth, and empty follicles. We placed her on Restasis(cyclosporin 0.05%, Allergan) instead, and after 3 months, she now has full healthy lashes and is very pleased. Another patient of mine returned to me recently after she was prescribed Latisse at a spa. She was a long-time patient of mine and had extensive history of blepharitis. While there was no flare-up of her blepharitis, I was disquieted that another clinician prescribed an eye medicine without consulting the ophthalmologist, especially a medicine that in my opinion may be contraindicated in her case. Nor did that clinician arrange any followup.Further research into Latisse's relationship to blepharitis revealed several areas for concern. First it is so far not well-studied. While prostaglandin analogs' effect on lash growth is wellknown in the ophthalmic community, actual publications on brimatoprost and hypotrichosis treament is surprisingly sparce. the most commonly cited source is a single case-report by Tosti in 2004. Many ophthalmologists have opined that blepharitis is a contraindication for brimatoprost use for lash growth, but few have offered evidence. Allergan's own package insert describes a "multicenter, doublemasked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment" Inclusion criteria was not described, nor is the study available to the public. Therefore it is not known if blepharitis was an exclusion criteria. However, an ongoing study registered by allergan, titled "Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin" does list preexisting blepharitis as an exclusion criteria. This Phase III tri-armed study (NCT00907426) was listed as received in May 2009 and "recruiting" as of Feb 6th, 2010. It is not clear the relationship between this study and the safety study listed in Latisse pocket insert. While it is reasonable to exclude blepharitis, which is a known cause of hypotrichosis, from an efficacy study, it calls into question its applicability to the general population, where blepharitis is a extremely common condition.
This leads to the second concern, which is that a common medical condition that is a known cause of hypotrichosis is not addressed in the promotion of this product. Blepharitis is listed as number six under "adverse reactions" in the package insert, and not listed under "Contraindication". Furthermore the adverse reactions section was quoted from previous studies involving brimatoprost in the IOP-lowering role, which used the same concentration, but a different vehicle. Therefore one is hard-pressed to accept Allergan's exclusion of blepharitis from the list of contraindications.
Lastly, the insert places a very limited role in physician consultation and follow-up. The patient is asked to see a physician prior to starting Latisse only if they are already on a prostglandin-analog for IOP-lowering purpose. Physician evaluation is recommended only if the patient:
develops a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions.
This places the burden on the patients to seek medical help after their pre-existing condition has been made worse by the product, when it could have been prevented by prior screening.
As an aesthetic surgeon, I do believe that Latisse is a valuable addition to our practice. However I also feeel that without proper screening by ophthalmologists, a large portion of the general public will experience undue adverse reactions to this product, and will ultimately hinder the product's gevity, as well as the public's trust. The AAO in its San Francisco meeting in 2009, has issued it's position. First among it's recommendations is to "see a doctor before starting Latisse." While broader than Allergan's own recommendation, it should go a step further and recommend seeing an ophthalmologist specifically. A family physician or a dermatologist simply do not have the instruments to evaluate for the cause of hypotrichosis appropriately. As Eye MD's, we are the one with the tools and know-how to protect the public against this potential epidemic. In addition, clinical studies of brimatoprost's effect on blepharitis are sorely needed. Potentially, a new paradigm for the treatment of hypotrichosis may involve anti-inflammatory therapy in some, and growth-promotion in others. Incidently both modalities are now available through Allergan, as Latisse and Restasis.
