Xiidra ( lifitegrast 0.5%) has just received FDA approval for the treatment of the signs and symptoms of dry eye. It is the first new drug that has been FDA approved in 13 years. Previously Restasis was approved for increasing the output of the lacrimal gland, it has been presumed that the gland does not work as well because of inflammation. Xiidra is the first dry eye drug to be approved for treating the signs and symptoms of dry eye. It is a drop used twice a day. It is manufactured by Shire and is expected to be released on the US market around September 2016. The cost is currently unknown but it is expected to be “competitive” as the manufacturer looks to build market share. The other drug on the market, Restasis is expensive. For uninsured patients, it can cost around $300 to $400 per month.
The reason this is an important new eye drop is because around 20% of the population suffer from dry eye and one of the hallmarks is increased inflammation on the surface of the eye. There are many ways this inflammation can arise e.g. mechanical irritation, an autoimmune response or due to the environment but inflammation is always present and this leads to further damage.
The safety and effectiveness of Xiidra has been studied in over 1000 patients in 4 different studies that lasted 12 weeks each. The studies showed an improvement after about 2 weeks of twice daily use. The main side effects were stinging on insertion, altered taste sensation and reduced vision in 5% to 25% of participants.
Xiidra reduces inflammation on the surface of the eye. The mechanics are not fully understood but it is a small molecule that blocks an important part of the inflammatory process. It does so in a way that is different to steroids and Restasis.
How eye doctors are going to use the drug is still up in the air at the moment. Is is going to be used with steroids, or before Restasis, or after Restasis? With experience, protocols will develop. It is not a cure for dry eyes, but it is certainly useful to have another drug that can suppress inflammation associated with dry eyes.