Masterarbeit

Prostaglandin analogues as lash enhancers - cosmetics or medicinal products?

Dr. Jana Nissen (2012)

Language: English

The demand for products to augment the prominence of eyelashes is growing. Several options for eyelash enhancement exist, but it is mostly limited to different
over the counter products including mascara and artificial eyelashes.

Prostaglandin analogues as for example bimatoprost or lanatoprost are used in eye drops for the management of ocular hypertension and for glaucoma patients. As a side effect, patients noticed darker, longer and fuller eyelashes. This observation raised the possibility for the aesthetic use of prostamides.

In 2008, the FDA approved Latisse® (by Allergan, Inc.), a bimatoprost containing drug (0.03%) for the use of darkening and lengthening eyelashes. The product is applied daily to the skin of the upper eyelid margin using applicators. The indication for the product is hypotrichosis of the eyelashes, the medical term for not having enough eyelashes.

Several cosmetic companies have released products based on prostaglandin analogues as cosmetics. The FDA has seized some of these products as unapproved and misbranded drugs and took regulatory action. The agency emphasized the possible side effects ranging from redness, itchiness, irritation, eyelid discolouration to a possible irreversible change of iris colour.

The FDA has clearly stated that products containing prostaglandin analogues are prescription drugs and not cosmetics, because the products affect the structure and function of the body and are not safe for use as over the counter products. In the European Union, no medicinal product for the treatment of hypotrichosis has been approved by the EMA until now. However, some products containing prostamides are sold in the internet as cosmetic products.

This master thesis focuses on the definition of cosmetics and medicinal products in the United States and the European Union. It has a look at the FDA position to Latisse® and other products containing prostaglandin analogues for lash enhancement. Furthermore, it is discussed how prostaglandin analogues for lash enhancement should be assessed. Some examples on the US and German market are presented and analysed.

Pages: 41