BLOG: Shire’s Xiidra (lifitegrast) approved

ByDarrell E. White, MD

That “whoosh” of wind you just felt coming from the general vicinity of Boston is the collective release of breath held by the now hundreds of folks working for the new eye care business unit at Shire. After a surprise expedited review, followed by a surprise delay and a surprise request for further data, the FDA yesterday approved Shire’s new drug application for the dry eye drug lifitegrast 2 weeks early. Surprise! This, in turn, took the lid off of the best kept secret in the industry, Xiidra, the brand name of the first new dry eye medicine in almost 15 years.

Really, though, anybody who was surprised by this just hasn’t been paying attention.

First, the science-guy kinda stuff. Dry eye disease (DED) is a chronic, progressive disease of the ocular surface. Conservative estimates are that there are 29 million sufferers in the United States alone. (I hold that the number is closer to 50 million.) Treating this inflammation has long been known to reduce or eliminate the signs of DED, and those of us in the trenches know that symptoms are relieved as well. Xiidra (lifitegrast ophthalmic solution) 5% is a first-in-class drug that prevents both T-cell recruitment and activation. The OPUS trials showed statistically significant improvement in both signs and symptoms of DED; Xiidra thus becomes the first medication approved for both indications.

Enough of the dry stuff. (See what I did there?) What does this mean out in the wild where we are treating DED every day? As I wrote last September, the single most important thing is that we now have two medicines specifically designed to treat this scourge. It really is that simple: two is better than one when looking to treat DED. The data suggest that lifitegrast will show a significant effect within 2 weeks, not as quick as a steroid but typically faster than what most of us have experienced with Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), for example. How this shakes out on the ground is yet to be seen, but one can easily see the benefit in the perioperative period. Speaking of steroids, we can all dust off those “ready lists” of patients on chronic steroid regimens and plug in Xiidra, even for (especially for?) those patients also on Restasis.

You did start that list last summer, didn’t you?

Believe it or not, the really hard work begins today for our friends at Shire. I’m betting that Bob Dempsey has three shifts going producing the stuff and that the widespread predictions of supply in the chain in the third quarter are reasonable. As excited as we in the “treat DED world” are, rest assured that our enthusiasm is hardly shared by those who pay for medications. The cold, dark reality of insurance coverage will likely descend on Xiidra like Harry Potter’s Dementors. We can’t ignore this, nor can Shire or for that matter our professional organizations. This is a medicine worth fighting for.

This is exciting. This is important. Shire has ushered Xiidra through the jungle that is the FDA, and in so doing has given us a totally new drug, right in the wheelhouse of those who treat DED. We will doubtless learn more about how to use this med in the next 12 months than in everything shown in all of the studies to date. Get started! As I’ve noted so many times, the patients are there. No matter where you fall out here in the trenches—doc, patient, or payer—this is a huge big deal.

[Tips cap] Good on ya, Shire. Take a big breath. Congrats, and thanks.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.