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''Xiidra® Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease''
Xiidra®* (Lifitegrast Ophthalmic Solution 5%) Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease
Cambridge, MA - January 3, 2018 - Shire plc (LSE: SHP, NASDAQ: SHPG) announced today 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,1 has been approved in Canada, marking the first international approval for the treatment outside of the U.S. Xiidra is the first new prescription medication for dry eye disease to be approved in Canada in seven years,2 providing patients with an effective treatment option for this common eye disease.3
Dry eye disease is one of the most prevalent conditions seen by eye care professionals and may affect up to 29 per cent of Canadians.4 The condition significantly affects vision-related quality of life and may impact activities such as reading, using computers, driving and watching television.5
"Many Canadians aren't aware of the chronic nature of dry eye disease, and the potential impact it can have on their eye health," says 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. "The approval of Xiidra in Canada gives patients a new option to address both the signs and symptoms of dry eye disease."
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 two, six 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.
full text:
http://markets.businessinsider.com/news/stocks/Shire-plc-Xiidra-Approved-by-Health-Canada-To-Treat-the-Signs-and-Symptoms-of-Dry-Eye-Disease-1012431743
''Xiidra® Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease''
Xiidra®* (Lifitegrast Ophthalmic Solution 5%) Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease
Canada approval represents Shire's first international market authorization for Xiidra outside of the United States.
Cambridge, MA - January 3, 2018 - Shire plc (LSE: SHP, NASDAQ: SHPG) announced today 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,1 has been approved in Canada, marking the first international approval for the treatment outside of the U.S. Xiidra is the first new prescription medication for dry eye disease to be approved in Canada in seven years,2 providing patients with an effective treatment option for this common eye disease.3
Dry eye disease is one of the most prevalent conditions seen by eye care professionals and may affect up to 29 per cent of Canadians.4 The condition significantly affects vision-related quality of life and may impact activities such as reading, using computers, driving and watching television.5
"Many Canadians aren't aware of the chronic nature of dry eye disease, and the potential impact it can have on their eye health," says 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. "The approval of Xiidra in Canada gives patients a new option to address both the signs and symptoms of dry eye disease."
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 two, six 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.
full text:
http://markets.businessinsider.com/news/stocks/Shire-plc-Xiidra-Approved-by-Health-Canada-To-Treat-the-Signs-and-Symptoms-of-Dry-Eye-Disease-1012431743
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