Xiidra Gets FDA Approval for Dry Eye

Written by Dr. David Evans   Last modified on August 6, 2018

Big news for all you chronic dry eye sufferers. The FDA just approved a new drug called Xiidra (lifitegrast ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease. The twice-a-day treatments are dosed 12 hours apart in each eye, with a 30-day supply estimated to cost in the neighborhood of $425.

Xiidra’s approval follows a lengthy clinical trial where more than a thousand patients were evaluated across multiple controlled studies. The approval actually comes later than anticipated after regulators requested further testing in 2015.

Technically Xiidra (Manufactured by Shire US Inc.) is the first drug to be approved for the specific purpose of treating dry eye, but it’s not the only game in town. In fact, it will be jumping into a prescription dry eye market already dominated by Allergan’s Restastis, which was approved back in 2003 for “tear production.”  Xiidra has the advantage over Restasis from a labeling point of view, but Restasis has more than 10 years of market exposure and a history of strong efficacy behind it. It also has firmly established prescription base and an extensive patient pool to draw from. Shire is hoping that Xiidra attracts its share of a growing dry eye medication market.

Restasis sales for 2015 topped the $1 Billion mark, so it will be interesting to see how the approval of Xiidra impacts sales for 2016 and beyond.

A Word About Dry Eye

Most of us experience some form of dry eye now and again. It can be caused by environmental factors such as dry weather or high winds, staring too long at a computer screen or TV, or even as a side effect of things like LASIK, cataract surgery, pregnancy or a vitamin imbalance. Minor cases are typically self-correcting and can respond well to over-the-counter lubricating eye drops, but the same cannot be said about chronic dry eye.

More than 16 million Americans suffer with dry eye disease, a more serious variant of the common eye condition that is marked by an insufficient flow of tears. The associated lack of eye lubrication causes all associated dry eye symptoms like burning, itching, stinging and redness. Untreated, chronic dry eye can be more than a simple nuisance. It can eventually cause ulcers or corneal scarring, which can further damage your vision.

Drugs like Restasis and now Xiidra are a welcome relief for the millions looking for dry eye relief.

Check out the FDA release regarding Xiidra