New Treatment for Dry Eye Approved by FDA – Lifitegrast (Xiidra)

There are an estimated 16 to 55 million people out there suffering from the symptoms of dry eye (irritation, redness, blurry vision, light sensitivity, double vision and foreign-body sensation are the most common symptoms) and the last drug treatment that was FDA-approved was in 2003. The decade-old drug is called cyclosporine (Restasis, Allergan) and while it is effective in reducing the symptoms of dry eye, it only works in a small percentage of patients. Other options for treating dry eye are supplemental artificial tears and occluding the normal tear draining mechanism of the eye to make our naturally produced tears last longer (silicone plugs that are inserted into the punctum and surgical closure of the punctum).

Credit: studyblue.com

Lifitegrast Ophthalmic Solution 5%

The FDA recently approved lifitegrast (Xiidra, Shire Ophthalmics) for the treatment of dry eye in patients 18-years-old and older. It is an eye drop given twice a day and in the ~1100 patients that received the drug in clinical trials, the investigators noted reduction in both the Eye Dryness Score and staining of the inferior cornea.

How it Works

Dry eye syndrome is primarily driven by inflammation and activation of T-cells. In order for those cells to get activated, surface receptors have to be activated. Lifitegrast inhibits that binding interaction by sitting on the T-cell and preventing a molecule called ICAM-1 from activating the T-cell. Lifitegrast may also inhibit secretion of inflammatory molecules called cytokines from other inflammatory cells in the eye.

The Unknown

The clinical trials that were used to gain FDA approval for lifitegrast only lasted 12 weeks, so we don’t know how well patients will do long term on this new drug. Will the effect last? Also, little is known about any long-term side effects of the medication (immediate side effects noted during the clinical trials included eye irritation, blurry vision and a strange taste sensation).

Ultimately, the approval of this new agent will allow ophthalmologists to have more options to treat our patients suffering from dry eye.