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FDA approves lifitegrast for dry eye disease
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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.
Perspective
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Penny A. Asbell, MD, FACS, MBA
I think the addition of a new treatment for dry eye is very exciting and certainly addresses an unmet medical need. Up to now, we’ve had limited opportunities for new treatments. This now broadens our ability to address this rather large patient population with a chronic pain syndrome which we call dry eye disease and typically is associated with variable vision, even interfering with driving, computer, reading and daily activities.
The key thing to remember is that lifitegrast is really continuing the paradigm change we saw with cyclosporine. That is, that dry eye disease is likely, at least in part, to have a pathogenesis that is inflammatory. This is another approach of an anti-inflammatory topical agent to treat dry eye disease. Shire has analyzed over 2,000 patients, some of them on placebo, some on the drug twice a day and has demonstrated improvements in symptoms and in signs and staining on the cornea. The symptoms might be a little hard to judge. From what I hear, this drop does cause a change in taste which might alert people that they’re taking the drops. However, we’ll have to see in the real world experience to understand its role in clinical care.I think it’s an exciting addition and it does support the mechanism of action of dry eye disease, meaning that inflammation is an important part of the disease and controlling inflammation is one way of approaching treatment.
One of the potential advantages of lifitegrast is that it’s a small molecule. It appears, at least by laboratory testing, that it may be much more potent than cyclosporine as a topical anti-inflammatory. The same group of drugs, LFA antagonists, have been used in systemic disease with some efficacy in psoriasis and other diseases. I think this is a good example of building an ophthalmic treatment based on information that’s known about systemic disease and drugs that work systemically. There is an open opportunity for all of us to be thinking about drugs that work in one area, which may well be effective for eye disease as well.
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