Shire’s recently-approved dry eye disease drug Xiidra is now available in the US, throwing down a challenge to Allergan’s rival therapy Restasis.
The Anglo-Irish company is making much of that fact that Xiidra (lifitegrast) – the first in a new class of lymphocyte function-associated antigen 1 (LFA-1) antagonist – is the only prescription eye drop cleared in the US for the treatment of signs and symptoms of the disease.
That gives Xiidra a broader label than Restasis (cyclosporine) that analysts suggest could catapult it to sales of $1bn or more. At present, Restasis’ label says it can be used to increase the eyes’ ability to produce tears, positioning it as a replacement for artificial tear products.
An estimated 16 million adults in the US are diagnosed with dry eye, a disease associated with inflammation that may eventually lead to damage to the surface of the eye and increases the risk of infections.
Shire chief executive Flemming Ornskov described Xiidra as “probably the most significant advance we’ve made in our pipeline recently,” and “potentially our biggest launch to-date”.
Shire has also priced its new drug at roughly the same level as Restasis – around $5,000 per year – setting up a head-to-head marketing battle between the two products.
Ornskov said recently it was well-advanced in formulary discussion in the US and he was confident that its clinical benefits would overcome any payer barriers.
To help take-up Shire has launched a phone service called ‘Ask Iiris’ which “offers live-person responses to questions regarding information about insurance coverage, benefits, co-pays and availability in pharmacies”.
There are no head-to-head trials of the two drugs, but clinical data suggest Xiidra may start to work more quickly, bringing relief within a couple of weeks as opposed to six weeks or more for Restasis.
Allergan made around $1.3bn in sales from Restasis last year, which made it the company’s second-biggest product after wrinkle treatment Botox. Some analysts believe the product could actually benefit from the increased awareness of dry eye disease that comes from having a rival in the marketplace.
Meanwhile, Shire will be able to point to Xiidra being the first new treatment for dry eye disease in 13 years as it starts to build its ophthalmics franchise, which has been effectively created through a series of acquisitions in the last three years. Xiidra came from its $160m purchase of SARcode Bioscience in 2013.