Shire files dry-eye drug lifitegrast for marketing approval

The drug, known by Xiidra for its brand name in the US, had been refused by the FDA after the agency required the company to provide more clinical data on the drug. It means that Shire is able to submit for European marketing approval with a substantial amount of clinical information to support it.

It means that Shire is able to submit for European marketing approval with a substantial amount of clinical information to support it.

Particularly, the company had conducted 5 separate clinical trials for the treatment that included more than 2,500 patients.

Since it was approved in the US, Xiidra has managed to gain $150 million in revenue. It arrived in the market as the second treatment to address dry eyes, with Regeneron’s Restasis having been on the market to treat chronic dry eye disease for the last decade.

Shire’s product, however, has managed to swipe 22% of the dry market since its launch. Analysts expect it to reach blockbuster levels by 2022, should approval in Europe go as planned.

Part of the reason for the product’s success in the US was noted by Shire’s CEO, Flemming Ornskov, as a direct result of its ‘awareness campaign’ to encourage more people to enquire about dry eye treatments from their physicians.

"This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person’s vision-related quality of life, affecting daily activities such as reading and using computers," said Howard Mayer, Head of Clinical Development, R&D at Shire. "Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients."

Entering into the ophthalmology market means a shift for the company that had focused on rare diseases previously. However, it is doubling down on its efforts in the area with a follow-up drug for dry eye conditions also in the pipeline, along with other treatments for infectious conjunctivitis and glaucoma