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Publication Exclusive: Now is the time to prepare for possible introduction of lifitegrast
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Summer is over, even for empty nesters like yours truly. It is “back to school” for all of us in the office, too, as many of us enter our busy seasons. Along with the usual sense of excitement in the air that comes with cooler nights and the sights and sounds of activity on the gridiron, we are on the edge of an exciting new age in the treatment of dry eye. Or maybe not. Or only sort of. I am talking, of course, of the impending FDA decision due on the filing of Shire’s new drug application for lifitegrast, a new medicine for the treatment of dry eye.
The only thing of which we can be certain is that you will soon become familiar with the heretofore forgotten term “dysgeusia.”
About lifitegrast
Shire announced earlier this year that the FDA had granted an expedited review of lifitegrast for the treatment of both the signs and symptoms of dry eye. The totality of results from four clinical trials with a total of 1,800 patients were included in Shire’s filing. Lifitegrast is a so-called small molecule integrin antagonist. It works at the level of the lymphocyte cell membrane to inhibit the binding of lymphocyte function-associated antigen (LFA-1) with its intercellular adhesion molecule (ICAM-1). This inhibition appears not only to prevent the recruitment and activation of lymphocytes, but also to disrupt binding that has already occurred.
The studies show an onset of action (reduced symptoms and/or signs) at approximately 2 weeks. Subjects who took lifitegrast had the usual assortment of ocular side effects (mild to moderate discomfort, drop site reaction), but interestingly, the percentage of subjects who dropped out of the safety study due to ocular side effects was higher in the placebo group. There was one significant non-ocular side effect clearly related to lifitegrast. You guessed it: dysgeusia, or altered sense of taste.
At the end of October, the FDA will approve lifitegrast, reject it outright or ask for additional information (as is often the case, additional studies are in progress). The FDA is playing this very close to the vest, and my guess is no better than yours as to which of these three outcomes we should expect. However, if we remember the similar period just before the approval of Restasis (cyclosporine ophthalmic emulsion 0.05%), the blockbuster drug made by Allergan that forever changed how we think about and treat dry eye, I think it is appropriate for us to start thinking about how we will use lifitegrast if it is, indeed, approved. I have a keen memory of doing this in the months leading up to the Restasis approval; doing so got our clinic off and running right away.
Before I start, let me point out that I am a paid consultant for both Allergan and Shire. As such, I am often privy to non-public information, both clinical and business in nature, from both companies. Everything noted thus far, and everything yet to come, is derived from fully public information that is readily accessible to everyone: published reports, posters at scientific meetings and posts on public websites such as Shire’s.
Click here to read the full publication exclusive, The Dry Eye, published in Ocular Surgery News U.S. Edition, September 25, 2015.