1.8 Lifitegrast

Final decision:

The delegate's final decision is to amend the Poisons Standard to include lifitegrast in Schedule 4 as follows:

Implementation date: 1 June 2018

Reasons:

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate include:

1. the risks and benefits of the use of a substance
   • Lifitegrast is a new chemical entity with no previous clinical or marketing experience in Australia. There is clinical and marketing experience with Lifitegrast internationally.
   • The medicine acts as an anti-inflammatory. It targets the interaction between lymphocyte function associated antigen and its cognate ligand intercellular adhesion molecule 1.
2. the purposes for which a substance is to be used and the extent of use of a substance
   • Lifitegrast will be used in 5% solution for the topical treatment of dry eye disease.
3. the toxicity of a substance
   • Low toxicity. There is sometimes mild eye irritation when the drops are installed. These effects are transient. As it is a topical medicine, reproductive effects are unlikely.
4. the dosage, formulation, labelling, packaging and presentation of a substance
   • 5% solution. The formulation for therapeutic use also contains sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and hydrochloric acid.
   • The dose is one drop twice daily.
   • The usual labelling for eye drops is appropriate.
   • The medicine will be presented in 0.2ml single use containers, packaged in foil pouches (5 per pouch) in a box containing 60. This will be sufficient for a patient to use the medicine for 30 days.