IMPORTANT
SAFETY
INFORMATION FULL
PRESCRIBING
INFORMATION PATIENT
INFORMATION MEDICAL
INFORMATION PATIENT
SITE

Melanie, a prior
user of artificial
tears

Name: Melanie

Age: 42

Occupation: Service coordinator for early intervention

Melanie was compensated for her time.

“Before I was diagnosed, I just went to my local pharmacy and if it was on the shelf, I bought it. The artificial tears just gave temporary relief. It wasn’t until I was prescribed Xiidra® and a few weeks in, that I started noticing real, lasting symptom relief.”

- Melanie

Xiidra is indicated for the treatment of signs and symptoms of dry eye disease (DED)

Clinical trial data

Xiidra reduced symptoms of eye dryness (based on EDS) at 2 weeks in 2 out of 4 studies, with improvement observed at 6 and 12 weeks in all 4 studies¹
Notable improvements in signs of dry eye disease: In 3 out of 4 studies, a larger reduction in Inferior fluorescein Corneal Staining Score (ICSS) favoring Xiidra was observed at 12 weeks¹

The safety and efficacy of Xiidra were assessed in four 12-week, randomized, multicenter, double-masked, vehicle-controlled studies (N=2133). Patients were dosed twice daily. The mean age was 59 years (range, 19-97 years). The majority of patients were female (76%). Use of artificial tears was not allowed during the studies. The study end points included assessment of signs (based on Inferior fluorescein Corneal Staining Score [ICSS] on a scale of 0 to 4) and symptoms (based on patient-reported EDS on a visual analogue scale of 0 to 100). Effects on symptoms of dry eye disease: a larger reduction in EDS favoring Xiidra was observed in all studies at day 42 and day 84. Xiidra reduced symptoms of eye dryness at 2 weeks (based on EDS) compared to vehicle in 2 out of 4 clinical trials. Effects on signs of dry eye disease: at day 84, a larger reduction in ICSS favoring Xiidra was observed in 3 out of the 4 studies.¹

- Melanie

Patient history

Symptoms of chronic eye dryness, irritation, and discomfort since 2015
Self-medication with OTC artificial tears for 2 years with temporary symptom relief
Wears glasses and contact lenses, but has reduced contact lens use

“At first, I thought the dryness and irritation were just because I was wearing my contacts while looking at a computer screen all day at work. I didn’t realize I had a disease that could be treated.”

- Melanie

Clinical presentation

Initial visit to Dr. Brujic: August 2017
Symptoms: Worsening eye dryness, redness, irritation, discomfort, and photophobia throughout the day
Artificial tear use: Using an increasing variety of OTC artificial tears frequently throughout the day

Diagnostic evaluation

Tear Breakup Time (TBUT) of 1 second (a value of <10 seconds may indicate a positive finding)²

Dry eye symptom impact

“I’m on a computer a lot, recording children’s fine motor skills. With my dry eye, I wasn’t as tuned in, and the kids sensed my frustration.”

“At every stoplight, I was using artificial tears for eye dryness and had fluctuating vision, even with my glasses on!”

“I felt helpless outside with my kids on windy days.”

Clinical evaluation: dry eye disease

Melanie’s eye care
provider and his plan

Mile Brujic, OD, FAAO

Dr. Brujic is a paid consultant for Novartis

“When I first saw Melanie in 2017, she had been dealing with chronic symptoms and self-medicating with artificial tears for 2 years. Her symptoms such as eye dryness, fluctuating vision, and short tear breakup time indicated DED. In my mind, she was a great candidate for Xiidra.”

- Dr. Brujic

Initial treatment plan

90-day Rx for twice-daily Xiidra¹*
Follow-up visit at 3 months

*Xiidra is an LFA-1 antagonist for the treatment of dry eye disease.

“Inflammation may be an underlying mechanism in dry eye disease. I wanted Melanie’s treatment to address the underlying inflammation.”

- Dr. Brujic

*Xiidra is an LFA-1 antagonist for the treatment of dry eye disease.

Patient counseling included:

Administration: Instructed Melanie to remove contact lenses before using Xiidra and wait at least 15 minutes before inserting¹
Safety profile: Reviewed contraindications and common side effects, which included instillation-site irritation, dysgeusia, and reduced visual acuity¹

“I find that when I tell my patients what they may expect with Xiidra, that it encourages them to stay on treatment.”

- Dr. Brujic

Melanie’s results at follow-up (3 months)

Melanie showed improvement in Inferior fluorescein Corneal Staining Score (ICSS)

Melanie had self-reported symptom improvement

Melanie experienced dysgeusia

“I noticed an improvement in my dry eye symptoms around 2 weeks after I started Xiidra. It wasn’t 100% better, but I could tell it was working. My eyes just felt better. They weren’t dry and gritty all the time. It was, and continues to be, a real relief for me.”

- Melanie

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.

Click here for Full Prescribing Information.

References

1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
2. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15(3):438-510.
3. US Food and Drug Administration. Code of Federal Regulations, Title 21, Volume 5 (21CFR349). Accessed July 12, 2022. https://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=349&showFR=1
4. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575-628.
5. Pflugfelder SC, Stern M, Zhang S, Shojaei A. LFA-1/ICAM-1 interaction as a therapeutic target in dry eye disease. J Ocul Pharmacol Ther. 2017;33(1):5-12.
6. US Food and Drug Administration. FDA approves new medication for dry eye disease. Published July 12, 2016. Accessed July 12, 2022. https://www.fda.gov/news-events/press- announcements/fda-approves-new-medication-dry-eye-disease
7. Data on file. DRF Fingertip Formulary® Novartis Pharmaceuticals Corp; July 2022.
8. Data on file. DRG Fingertip Formulary® incorporating Payer Sciences business rules as of July 12, 2022.
9. Zhong M, Gadek TR, Bui M, et al. Discovery and development of potent LFA-1/ICAM-1 antagonist SAR 1118 as an ophthalmic solution for treating dry eye. ACS Med Chem Lett. 2012;3(3):203-206.
10. Perez VL, Pflugfelder SC, Zhang S, Shojaei A, Haque R. Lifitegrast, a novel integrin antagonist for treatment of dry eye disease. Ocul Surf. 2016;14(2):207-215.

References

1. Farrand KF, Fridman M, Stillman IÖ, Schaumberg DA. Prevalence of diagnosed dry eye disease in the United States among adults aged 18 years and older. Am J Ophthalmol. 2017;182:90-98.
2. Data on file. Jefferies Franchise Note. Equity Research Americas. Novartis Pharmaceuticals Corp; May 2017.
3. Dana R, Bradley J, Guerin A, et al. Estimated prevalence and incidence of dry eye disease based on coding analysis of a large, all-age United States health care system. Am J Ophthalmol. 2019;202:47-54.
4. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575-628.
5. US Food and Drug Administration. Code of Federal Regulations, Title 21, Volume 5 (21CFR349). Accessed July 12, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=349&showFR=1
6. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15(3):438-510.
7. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276-283.
8. American Academy of Ophthalmology. Dry Eye Syndrome Preferred Practice Pattern®. Accessed July 12, 2022. https://www.aao.org/Assets/8bb0fe82-84c8-4020-89e6- e123667fb654/636777165099570000/dry-eye-syndrome-preferred-practice-pattern- 2018-pdf
9. Matossian C, McDonald M, Donaldson KE, Nichols KK, Maclver S, Gupta PK. Dry Eye Disease: Consideration for women’s health. J Womens Health (Larchmt). 2019;28(4):502-514.
10. Pflugfelder SC, de Paiva CS. The pathophysiology of dry eye disease. Ophthalmology. 2017;124:S4-S13.
11. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
12. Pflugfelder SC, Stern M, Zhang S, Shojaei A. LFA-1/ICAM-1 interaction as a therapeutic target in dry eye disease. J Ocul Pharmacol Ther. 2017;33(1):5-12.
13. Perez VL, Pflugfelder SC, Zhang S, Shojaei A, Haque R. Lifitegrast, a novel integrin antagonist for treatment of dry eye disease. Ocul Surf. 2016;14(2):207-215.

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.

Click here for Full Prescribing Information.

Melanie, a prior user of artificial tears

Xiidra is indicated for the treatment of signs and symptoms of dry eye disease (DED)

Patient history

Clinical presentation

Diagnostic evaluation

Dry eye symptom impact

Clinical evaluation: dry eye disease

Melanie’s eye care provider and his plan

Initial treatment plan

Patient counseling included:

Melanie’s results at follow-up (3 months)

Melanie, a prior
user of artificial
tears

Melanie’s eye care
provider and his plan