The dosing, or posology, of prescription medications is refined early on in clinical development. Drug concentration in approved medications balances safety and efficacy as well as side effects. Since the binding affinity and receptor activation relate to potency, ICP in OTC ELGS is predicted to be similar to the glaucoma medication travoprost. The concentration of ICP in OTC ELGS is predicted to be higher than glaucoma medications, given the high frequency of PGA-related side effects among users.5
Multiple patents for different PGAs are found online. Not all PGAs make it through early clinical development; some are abandoned for drug development due to inadequate IOP reduction and/or side effects. However, just because a molecule failed to be selected for development as an FDA-approved drug does not mean it’s without the multiple, common, recognizable and predictable side effects characteristic of the PGE2 class. Class action lawsuits have been filed in the United States for failure to disclose the risks associated with PGAs, and drug safety watchdogs have called out the issue of using PGAs in cosmetics for failing to disclose its risks.7
RULES AND WORDSMITHING
Latisse (bimatoprost 0.03%, AbbVie), a PGA, is the only FDA-approved medication indicated for “hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.”8 Physician confidence is bolstered knowing that side effect and safety information is included with each package and is helpful when counseling patients.
Unfortunately, however, OTC ELGS aren’t properly tested for safety, and the risks that characterize the PGA class and the drug concentrations are not disclosed.9 Despite the predictable and expected PGA side effects, cosmetics companies carefully wordsmith their claims and marketing to hide under the “cosmetics” category. They play in a grey area by focusing on the appearance of longer, thicker lashes to carefully avoid direct claims of giving longer, thicker lashes. The product warnings are insufficient and would never pass muster as a prescription, yet the active ingredient ICP is likely just as potent as travoprost. Furthermore, many patients assume that OTC cosmetics are safe. They are understandably shocked and angry when they discover that the OTC products they purchased for eyelash growth are contributing to their ocular surface disease (OSD).
BEWARE OF OTHER DANGERS
We need to be wary of other deleterious eyelash practices. Patients’ failure to remove their makeup at night can also contribute to their dry eye disease.
Research has shown that patients who did not remove their makeup at night had higher dry eye symptoms and statistically significantly higher Standard Patient Evaluation of Eye Dryness (SPEED) scores than patients who removed their makeup.10 Research in this area has continued, and reveals that more than half of patients use two or three different makeup removers each night.11 This has the potential to compound the chemical insults to the ocular surface of the dry eye patient.
We’ve all seen patients who removed their makeup yet still have significant cosmetics debris on their lids and tear film (Figure 2). The chemicals in makeup removers may not be ocular surface friendly, thus further compounding the issue. For example, benzalkonium chloride (BAK) is the leading liquid makeup remover. Given the FDA cosmetics-labeling requirements of listing ingredients in descending order of amounts, the position on the list of BAK means it is possible that the final BAK concentration in some liquid eye-makeup removers is far higher than anything in ophthalmic prescription drops.