Shire announced that »Xiidra (lifitegrast ophthalmic solution 5%), a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adults, has been approved in Canada, marking the first international approval for the treatment outside of the United States. Xiidra is the first new prescription medication for dry eye disease to be approved in Canada in seven years, providing patients with an effective treatment option for this common eye disease.
Dry eye disease is one of the most prevalent conditions seen by eye care professionals and may affect up to 29 percent of Canadians, according to Shire. The condition significantly affects vision-related quality of life and may impact activities such as reading, using computers, driving and watching television.
“Many Canadians aren’t aware of the chronic nature of dry eye disease, and the potential impact it can have on their eye health,” Dr. W. Bruce Jackson, an ophthalmologist specializing in cornea and external disease with a special or primary interest in ocular surface disease and dry eye disease, said in a company news release. “The approval of Xiidra in Canada gives patients a new option to address both the signs and symptoms of dry eye disease.”
The approval of Xiidra is supported by the largest development program globally to date for an investigational-stage dry eye disease therapy, consisting of five clinical trials with more than 2,500 patients, according to Shire. In four safety and efficacy studies, Xiidra improved symptoms as measured by patient-reported eye dryness score (EDS), and in three of the four studies improved the objective signs of dry eye disease (measured using corneal staining).
“Xiidra is Shire’s entry into the eye care market, and represents our commitment to ophthalmics,” Howard B. Mayer, MD, Chief Medical Officer, Research and Development, Shire, said in the news release. “It’s important that we successfully deliver innovative treatments for patients worldwide, so we’re pleased to now be able to make Xiidra available in Canada.”
Xiidra will be available for patients in Canada in early 2018.
Xiidra in Clinical Trials
A larger reduction in eye dryness score (EDS) favouring Xiidra was observed in all four efficacy studies at week six and week 12. In two clinical trials, symptom improvement was noted at 2, 6 and 12 weeks. A long-term safety study randomized to either Xiidra (n=220) or placebo (n=111) over 360 days found Xiidra to be generally well-tolerated with no serious treatment-emergent ocular adverse events.
The most common ocular adverse reactions were eye irritation (18%), eye pain (13%) and instillation site reactions (12%). The majority of ocular adverse reactions were mild and transient in nature. The most common non-ocular adverse reaction was altered taste sensation (dysgeusia) (14%).8