Dry Eye Disease Treatment Xiidra Approved by FDA

Shire announces that the U.S. Food and Drug Administration (FDA) has approved 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 adult patients.

Shire expects to launch Xiidra in the United States in the third quarter of 2016.

“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition,” said Flemming Ornskov, M.D., MPH, CEO, Shire. “As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs. We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”

The safety and efficacy of Xiidra was studied in 1,181 patients (of which 1,067 patients received lifitegrast 5%) in four placebo-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. Assessment of symptoms was based on change from baseline in patient reported eye dryness score (EDS; 0-100 visual analogue scale).

Read the full press release here.

Featured Posts

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Learn More

In Perfect Harmony

Dress your eyes in a showstopping synchronous design from VANNI's Tandem collection.

Learn More

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Read more

SightGlass Vision Releases First White Paper on Diffusion Optics Technology™

SightGlass Vision announced the release of its first white paper regarding the company’s Diffusion Optics Technology™ (DOT 0.2) spectacle lenses.

Read more

Companies Nominated at the 30th SILMO d’Or

The 2023 SILMO d'Or nominees are...

Read more

Nicolas Fafiotte Appointed President of the 2023 SILMO D’OR Awards

A graduate of the ESMOD School of Fashion Design, Nicolas Fafiotte trained in Paris before moving to Lyon in the early 2000s.

Read more

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Learn More

In Perfect Harmony

Dress your eyes in a showstopping synchronous design from VANNI's Tandem collection.

Learn More

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Read More

SightGlass Vision Releases First White Paper on Diffusion Optics Technology™

SightGlass Vision announced the release of its first white paper regarding the company’s Diffusion Optics Technology™ (DOT 0.2) spectacle lenses.

Read More

Companies Nominated at the 30th SILMO d’Or

The 2023 SILMO d'Or nominees are...

Read More

Nicolas Fafiotte Appointed President of the 2023 SILMO D’OR Awards

A graduate of the ESMOD School of Fashion Design, Nicolas Fafiotte trained in Paris before moving to Lyon in the early 2000s.

Read More

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Learn More

In Perfect Harmony

Dress your eyes in a showstopping synchronous design from VANNI's Tandem collection.

Learn More

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Read more

SightGlass Vision Releases First White Paper on Diffusion Optics Technology™

SightGlass Vision announced the release of its first white paper regarding the company’s Diffusion Optics Technology™ (DOT 0.2) spectacle lenses.

Read more

Companies Nominated at the 30th SILMO d’Or

The 2023 SILMO d'Or nominees are...

Read more

Nicolas Fafiotte Appointed President of the 2023 SILMO D’OR Awards

A graduate of the ESMOD School of Fashion Design, Nicolas Fafiotte trained in Paris before moving to Lyon in the early 2000s.

Read more

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Learn More

In Perfect Harmony

Dress your eyes in a showstopping synchronous design from VANNI's Tandem collection.

Learn More

Transitions®: the clear lens that adapts to light for the perfect protection!

Did you know Transitions® has a lens for all your patients experiencing any level of light sensitivity?

Read more

SightGlass Vision Releases First White Paper on Diffusion Optics Technology™

SightGlass Vision announced the release of its first white paper regarding the company’s Diffusion Optics Technology™ (DOT 0.2) spectacle lenses.

Read more

Companies Nominated at the 30th SILMO d’Or

The 2023 SILMO d'Or nominees are...

Read more

Nicolas Fafiotte Appointed President of the 2023 SILMO D’OR Awards

A graduate of the ESMOD School of Fashion Design, Nicolas Fafiotte trained in Paris before moving to Lyon in the early 2000s.

Read more