Two years ago, Robert Dempsey joined Shire to build the pharma giant’s new ophthalmology unit.
Rather than acquire a portfolio of established products to build a commercial base, Shire bet big, building out a pipeline of clinical-stage therapeutics.
On Monday, its biggest bet paid off when the FDA approved Xiidra (lifitegrast ophthalmic solution), a twice-daily eye drop solution as a treatment for dry eye, the first such approval in over a decade.
Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition.
“This would give Xiidra clinical differentiation versus Restasis (indicated for tear production) as well as the benefit of a faster onset of action,” writes Peter Verdult, analyst at Citi. “Shire plans to launch the product in the US in 3Q16. We expect regulatory plans to be disclosed for Europe and Japan later in the year.”
The news was welcomed at Shire and across ophthalmology.
“The approval of Shire’s Xiidra is an important development in the treatment of dry eye,” states Eric Donnenfeld, MD, clinical professor of ophthalmology at NYU and founding partner of Ophthalmic Consultants of Long Island. “It adds a second immunomodulator to the armamentarium of dry eye therapy and the first in over a decade.”
“Xiidra has a unique mechanism of action notable for a rapid improvement in signs and symptoms which will be very much appreciated by patients and eye care practitioners alike,” Donnenfeld wrote in an email.
Vance Thompson, MD, director of refractive surgery for Vance Thompson Vision in Sioux Falls, SD and professor of ophthalmology at the Sanford USD School of Medicine, , agrees Xiidra is a welcome addition.
But he’s also encouraged by what doors the approval could open for future products. “It was a big trial and a well-run trial,” Thompson says. “I’m not only excited for patients with dry eye but also for future companies that will have something to learn from when they try to navigate FDA approval.”
Shire acquired then-lifitegrast in 2013 through the acquisition of privately held SARcode Bioscience Inc. That company worked with Ora to develop the early clinical trials. George Ousler, vice president of dry eye at Ora, says the company is “thrilled” by the approval “The FDA has been very clear about their expectations for approval of a dry eye product,” he says. “We have seen tremendous consistency across our many regulatory interactions with the agency.”
Citi forecasts that global sales for Xiidra could reach $1.8 billion in 2025. A recent survey of ophthalmologists by Citi suggests there is pent up demand to try Xiidra in patients who haven’t responded to Restasis.
The analyst did warn that Shire’s pursuit of a significant premium to Restasis could backfire if Restasis trends are any indication. Half of the patients who stop using Restasis cite price as the reason.
“We remain comfortable with our peak sales assumption for Xiidra and expect a vigorous response from market leader Allergan,” Verdult writes. Allergan, of course, acquired Oculeve, a medtech company developing a neurostim device that could alleviate the discomfort of dry eye.
Listen to this OIS podcast with Shire’s Robert Dempsey to hear what’s next for the Dry Eye treatment and what else we can expect to see from Shire’s pipeline.