HELP PATIENTS GET STARTED BY DISCUSSING POTENTIAL AEs

Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients1

The most common AEs reported in 5%-25% of patients across 5 clinical studies1*

  • Lasting symptom relief in 2 weeks icon

    Instillation-site

    irritation

  • Address the signs of dry eye disease icon

    Dysgeusia

  • Safety data in clinical trials icon

    Reduced

    visual acuity

*In 5 clinical studies of dry eye disease with lifitegrast ophthalmic solution, 1401 patients received at least 1 dose of lifitegrast (1287 of whom received Xiidra). The majority of patients (84%) had up to 3 months of treatment exposure; 170 patients were exposed to Xiidra for approximately 12 months.1

MOST FREQUENT AEs (>5%) IN THE 12-MONTH SONATA SAFETY STUDY2†‡§

The majority of treatment-emergent AEs were mild to moderate in severity

Values inside bars=number of participants.

The 1-year, multicenter, randomized, prospective, double-masked, placebo-controlled, phase 3 SONATA study evaluated the safety of Xiidra compared to vehicle in 331 adult patients who had a self-reported history of dry eye disease. Artificial tear use was assessed as an exploratory endpoint.2

Adverse events occurring in >5% of participants in either treatment group.2

§In the SONATA study, a total of 24 participants (Xiidra, 8.2% [18/220] vs vehicle, 5.4% [6/111]) had at least 1 ocular treatment-emergent adverse event (TEAE) and 13 participants had at least 1 nonocular TEAE (Xiidra, 4.1% [9/220] vs vehicle, 3.6% [4/111]) that resulted in discontinuation.2

Percentage value indicates the proportion of participants who experienced each type of adverse event.2

Low Discontinuation Rates2,3

Among participants treated with Xiidra in the SONATA safety study and a pooled analysis of four 12-week studies3

Greater than 2%

discontinued due to instillation-site reaction and dysgeusia3

Greater than 1%

discontinued due to instillation-site irritation
or pain3

Greater than 2%

discontinued due to reduced visual acuity2

Patients taking Xiidra had the lowest discontinuation rate after their first Rx compared with cyclosporine

Nearly 88% of patients remained on Xiidra after 1 year in the SONATA safety study2†

In addition to potential AEs,
every patient prescribed Xiidra should know

THE COMFORT OF XIIDRA MAY IMPROVE OVER TIME3-6

Drop comfort score improvements were seen across 3 clinical trials from 2 weeks to 12 weeks at 3 minutes
post instillation3-6¶

A box of Xiidra 60 single use containers
quot

The most exciting part about Xiidra is the patients that come back and want to still be on the medication.”

Dr Preeya Gupta, Ophthalmologist, Triangle Eye Consultants

EXTENSIVE ACCESS

~90% overall coverage for commercial and Medicare Part D patients nationwide7#

XIIDRA MAY HELP

Xiidra can start to deliver symptom relief as early as 2 weeks1**

AE, adverse event.

The 1-year, multicenter, randomized, prospective, double-masked, placebo-controlled, phase 3 SONATA study evaluated the safety of Xiidra compared to vehicle in 331 adult patients who had a self-reported history of dry eye disease. Artificial tear use was assessed as an exploratory endpoint.2

Drop comfort was measured based on patient-reported scores from 0 (very comfortable) to 10 (very uncomfortable).3

#Based on data from April 2024. Up to 95% of commercial and 71% of Medicare Part D patients may be covered.7

**Xiidra significantly reduced symptoms of eye dryness at 2 weeks (based on Eye Dryness Score compared to vehicle) in 2 of 4 studies, with improvements observed at 6 and 12 weeks in all 4 studies.1

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Indication and important safety information

Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

  • Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients.
  • In clinical trials, the most common adverse reactions reported in 5-25% of patients were instillation site irritation, dysgeusia and reduced visual acuity. Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
  • To avoid the potential for eye injury or contamination of the solution, patients should not touch the tip of the single-use container to their eye or to any surface.
  • Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.
  • Safety and efficacy in pediatric patients below the age of 17 years have not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information for Xiidra.

References

  • Xiidra. Prescribing information. Bausch & Lomb Inc.
  • Donnenfeld ED, Karpecki PM, Majmudar PA, et al. Safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease: a 1-year, multicenter, randomized, placebo-controlled study. Cornea. 2016;35(6):741-748.
  • Nichols KK, Donnenfeld ED, Karpecki PM, et al. Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease. Eur J Ophthalmol. 2019;29(4):394-401.
  • Data on file. 1118-KCS-200: OPUS-1 Clinical Study Report, December 2013. Bausch & Lomb Inc.
  • Data on file. 1118-DRY-300: OPUS-2 Clinical Study Report, March 2014. Bausch & Lomb Inc.
  • Data on file. SHP606-304: OPUS-3 Clinical Study Report, December 2015. Bausch & Lomb Inc.
  • Data on file. MMIT Portal, April 2024. Bausch & Lomb Inc.

Indication and important safety information

Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

  • Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients.
  • In clinical trials, the most common adverse reactions reported in 5-25% of patients were instillation site irritation, dysgeusia and reduced