New Dry Eye Medication? The Latest News on Lifitegrast

With the patent set to expire for Restasis this month, the dry eye world is poised to have a new option on the block with Shire's lifitegrast molecule that is just reporting Phase 3 clinical trial data.  When Restasis first hit the market in 2002, it was the first prescription available for dry eye, showing increased tear production for patients and an anti-inflammatory effect.  For over a decade Restasis has been your doctor's only prescription choice for a drop to help produce more tear film, but due to the varied issues that cause dry eye, it has not been a cure-all for every type of dry eye sufferer.  Here is what we know about the potential new kid on the block:

Lifitegrast is an anti-inflammatory molecule, working to reduce T-cell activation and cytokine release.  Anti-inflammatories like Restasis and lifitegrast theoretically combat dry eye by breaking the inflammatory cycle.  When your eye gets dry, redness and irritation result from increased inflammation on the eye's surface.  This inflammation appears to reduce normal tear film function, causing more dryness and more inflammation.  It is a never-ending circle of dryness, redness, and discomfort.  Both Restasis and lifitegrast are T-cell modulators, but it is theorized that lifitegrast will be faster-acting than the Restasis molecule. Restasis typically requires around 3 months (the lifespan of a T-cell) to begin effectively breaking the dry eye cycle, whereas early data suggests lifitegrast will begin having effects in as early as 2 weeks.  There are at this time no head-to-head studies that compare the two drugs.  Potentially they could even be used in combination for a greater effect!

Lifitegrast is completing Phase 3 FDA trials, and so far results have been mixed.  All trials so far compare lifitegrast to placebo (the vehicle in the drug).

SPK or corneal staining is a clinical sign of moderate to severe dryness.
Unfortunately lifitegrast performed no better than its placebo at
improving SPK on the surface of the eye in the OPUS-2 study.  Patients
did however report improvement of their dry eye symptoms in the blind
study.  via

In the OPUS-2 study, paitients reported a  statistically significant relief from dryness symptoms with lifitegrast versus placebo.  Unfortunately the clinical signs of dryness measured in the study (inferior corneal staining) was not statistically significantly improved with the use of the drug.  Thus continues the infuriating issue with dry eye -- symptoms and signs of dryness tend not to coincide.  So while patients felt better, the clinical findings of dryness and damage on the surface of the eye (corneal staining in this study) had not improved.

In the SONATA safety study, there were no reported dangerous side effects with lifitegrast use. The most common side effect was bad after-taste (16.2% of users) and irritation after installation (7.8%).  Burning with installation is also a common complaint with Restasis use.

While there is no way to accurately predict when or if lifitegrast will come to market as a true alternative or additive therapy to Restasis treatment, it can be several years before a drug with successful phase 3 trials actually makes it to market.  I will continue to keep you updated as we learn more!