FDA approves lifitegrast for dry eye disease
The FDA has approved Xiidra for the treatment of signs and symptoms of dry eye disease in adults, Shire announced in a press release.
Twice-daily Xiidra (lifitegrast ophthalmic solution 5%) is the first prescription eye drop solution indicated for the treatment of both signs and symptoms of dry eye disease, the release said.
John A. Hovanesian
“Xiidra is the first drug approved for the treatment of dry eye since Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), 13 years ago,” John A. Hovanesian, MD, FACS, OSN Cataract Surgery Section Editor, told Ocular Surgery News. “FDA studies including 2,500 patients, in which my practice took a small part, showed a clear benefit to lifitegrast in reducing both symptoms and signs of this potentially debilitating disease. Moreover, patients had no significant side effects.”
The approval is based on the results of four placebo-controlled clinical trials that assessed Xiidra’s effect on the signs and symptoms of dry eye disease at baseline, 2 weeks, 6 weeks and 12 weeks. In the Xiidra group in all four studies, there was a larger reduction in eye dryness score at 6 weeks and 12 weeks. In three of the four studies, a larger reduction in inferior corneal staining score was seen at 12 weeks in the Xiidra group.
The most common side effects included irritation at the instillation site, dysgeusia and reduced visual acuity, reported in 5% to 25% of patients.
“The drug treats dry eye with a new mechanism of action and will certainly be a valuable part of our treatment toolbox,” Hovanesian told OSN. “Both eye care professionals and patients should be grateful to Shire for having the bravery to pursue approval of a dry eye drug, an indication where so many other drugs and companies have failed.”
The company expects to launch Xiidra in the U.S. in the third quarter.
Disclosure: Hovanesian reports he is a consultant and medical advisory board member for Shire.