Preservatives, generics and ocular surface

Abstract

AbstractMost eye drops sold in many European countries are generic. While one would expect generic drugs to be a true copy of the original eye drop, there are surprisingly few requirements for the introduction of a copy eye drop on the market. Thus, only the concentration of the active ingredients should be identical to the concentration of the original product. Since many other factors such as bottle material, bottle shape and size and lid colour, droplet size, pH, viscosity, buffer capacity can affect the effect, there is concern about whether generics are identical to their original variants. In addition to the few requirements for the introduction of generic drugs, the replacement of preservatives in eye drops with the same active substance is legal. In general, preservatives have a negative effect on the surface of the eye due to their toxic effect on, among other things, the ocular surface cells and on the tear film. Here, a brief overview of the concerns and facts about generics and the use of preservatives in eye drops will be given.