Basel, July 1, 2019 - Novartis today announced that it has completed its acquisition of Xiidra (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease.
Marie-France Tschudin, President, Novartis Pharmaceuticals, said: "This deal delivers on our ongoing commitment to reimagine medicine for patients suffering from a variety of eye diseases, while also laying critical groundwork for future, potential front-of-the-eye pipeline products we have in development."
Xiidra is a prescription eye drop solution designed to treat the signs and symptoms of dry eye disease. It is dosed twice per day, approximately 12 hours apart, in each eye. Xiidra is approved to treat signs and symptoms of dry eye disease in multiple markets including the US, Canada and Australia. It is under regulatory review in a number of additional markets.
Approximately 1000 patients were treated with Xiidra in four vehicle-controlled 12-week trials. Each of the four studies assessed the effect of Xiidra on both the signs and symptoms of dry eye disease at baseline, week two, six and 12 .
In three of the four studies, a larger reduction in the eye dryness score (EDS) was observed with Xiidra at six and 12 weeks. In two of the four studies, an improvement in EDS was seen with Xiidra at two weeks. At week 12, a larger reduction in inferior corneal staining score (ICSS) favoring Xiidra was observed in three of the four studies. The most common adverse reactions reported in 5 to 25 percent of patients were instillation site irritation, altered taste sensation (dysgeusia) and reduced visual acuity.