Ar’Tee, a patient who addressed his dry eye symptoms head-on
Name: Ar’Tee
Age: 46
Occupation: Program Manager for Department of Veterans Affairs
Ar’Tee was compensated for his time.
“My eyes had felt irritated for a while. When it started to get really bad, I decided I had to talk to an eye doctor. After trying an artificial tear, I got temporary relief, but I needed more. I’m glad after just a few weeks I was prescribed Xiidra®.”
- Ar’Tee
Patient history
- Symptoms of eye irritation, pain, itchiness, and feeling of debris in the eye since the summer of 2020
- Has 20/20 vision without corrective lenses
“It literally felt like sandpaper grinding on my eyeballs. That was super uncomfortable, I don’t wish that feeling on anybody.”
- Ar’Tee
Clinical presentation
- Initial visit to Dr. Davison in July 2020; experienced mild infrequent symptoms that gradually progressed over time
- Symptoms: Eye pain, itch, and irritation
- Treatment history: Artificial tear use (provided temporary relief) and topical antibiotic for suspected infection
Clinical trial data
- Xiidra reduced symptoms of eye dryness 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
Relevant Xiidra clinical trial information
Xiidra is indicated for the treatment of signs and symptoms of dry eye disease (DED).
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
Lissamine green
Lissamine green staining was graded using a 5-point scale (0=none, 4=severe; 0.5 point increments) by region (temporal and nasal). Staining scores below represent the total conjunctival region.2
- Phase II: Mean lissamine green staining scores at baseline were 3.12, with a mean change from baseline to day 84 of 0.13 in the 5.0% lifitegrast group vs a mean score of 3.31 at baseline, with a mean change from baseline to day 84 of 0.11 in the placebo group.3
- OPUS-1: Mean lissamine green staining scores at baseline were 7.09, with a mean change from baseline to day 84 of -0.72 in the 5.0% lifitegrast group vs a mean score of 6.94 at baseline, with a mean change from baseline to day 84 of -0.30 in the placebo group. Change from baseline to day 84 was calculated using a pre-CAE baseline value.4
- OPUS-2: Mean lissamine green staining scores at baseline were 4.02, with a mean change from baseline to day 84 of -0.54 in the lifitegrast group vs a mean score of 4.03 at baseline, with a mean change from baseline to day 84 of -0.55 in the placebo group.5
- OPUS-3: Mean lissamine green staining scores at baseline were 2.09, with a mean change from baseline to day 84 of -0.34 in the lifitegrast group vs a mean score of 2.14 at baseline, with a mean change from baseline to day 84 of -0.24 in the placebo group.2
OSDI
OSDI (ocular surface disease index) was a 12-question, subject-related, dry eye disease index (0-100 scale; 0=normal, 100=severe). OSDI scores are not available for OPUS-3. OSDI scores below represent the total OSDI score.3
- Phase II: Mean OSDI scores at baseline were 31.77, with a mean change from baseline to day 84 of -4.65 in the 5.0% lifitegrast group vs a mean score of 28.84 at baseline, with a mean change from baseline to day 84 of -0.09 in the placebo group.3
- OPUS-1: Mean OSDI scores at baseline were 26.03, with a mean change from baseline to day 84 of -2.98 in the lifitegrast group vs a mean score of 27.05 at baseline, with a mean change from baseline to day 84 of -3.84 in the placebo group.4
- OPUS-2: Mean OSDI scores at baseline were 40.78, with a mean change from baseline to day 84 of -13.77 in the lifitegrast group vs a mean score of 39.83 at baseline, with a mean change from baseline to day 84 of -7.69 in the placebo group.5
Lissamine green staining scores were analyzed as a secondary efficacy endpoint in Phase II and OPUS-2, as a tertiary efficacy endpoint in OPUS-1, and as an assessment related to safety in OPUS-3. OSDI scores were analyzed as a secondary efficacy endpoint in Phase II and OPUS-1, and as a tertiary efficacy endpoint in OPUS-2.2-5
Phase II and OPUS-1 were CAE (controlled adverse environment) studies. The controlled adverse environment procedure was used to enrich the study population at screening by identifying subjects with the ability to exacerbate both signs (inferior cornea staining) and symptoms (ocular discomfort score) following 90 minutes of exposure. In Phase II study, a total of 5 challenges with the CAE were scheduled during screening and treatment (1 CAE at each visit). Ocular assessments and subject self-assessments were conducted prior to, during, and following each CAE in both eyes. In OPUS-1, a total of 2 screening challenges with the CAE were scheduled during the Screening Period; the CAE was not used to assess subjects during the Treatment Period.3,4,6
Diagnostic evaluation of Ar'Tee
- Dry eye disease associated with meibomian gland dysfunction findings
- Lissamine green staining of 2-3+ and NaFl staining revealing evidence of dry eye disease
- Meibography7:
- Lower lids OU showed 25%-50% meibomian gland loss
- Upper lids showed 0%-25% meibomian gland loss
- No corneal staining was performed at this point
Ocular Surface
Disease Index Score8
Dry eye symptom impact
“I wasn’t comfortable looking at a computer screen all day while I was working from home.”
“Sometimes it was hard to drive at night.”
“My eyes were bothering me a lot and making it difficult for me sometimes.”
Clinical evaluation: dry eye disease
Ar’Tee’s eye care provider and her plan
Janelle Davison, OD/Optometrist
Dr. Davison is a paid consultant for Novartis.
“When I first saw Ar’Tee, he reported pain and itch in his eyes. It’s likely that Ar’Tee had some signs and symptoms preceding the event that caused him to go to his primary care physician. After running the lissamine green staining test and seeing his OSDI scores, it was clear that he had dry eye disease and would be a good candidate for prescription Xiidra®.”7
- Dr. Davison
Initial treatment plan
- 90-day Rx for twice-daily Xiidra1
- Eyelid wipes9
- Apply warm compresses9
- Omega-3 fish oils9
- In-office device therapy9
“Ar’Tee responded incredibly well to treatment with Xiidra after 2 weeks. His response was very good to see in that short period of time.”
- Dr. Davison
Patient counseling included:
- Administration: Patient was advised to apply the Xiidra drops twice per day, one in each eye, 12 hours apart1
- Safety profile: Dr. Davison reminded Ar’Tee that there are some potential side effects, such as blurred vision and burning1,10
"I am always certain to demonstrate to the patient that this is not going to be a quick fix. For Ar’Tee, Xiidra was part of a long-term management plan for dry eye disease as we worked to alleviate his painful symptoms."
- Dr. Davison
Ar’Tee’s results at follow-up (3 months)
Improvement in OSDI and lissamine green staining scores from baseline are as follows:
Ocular surface
disease index score8
Lissamine green
staining score
Improvement in
dry eye symptoms
“I wanted to provide an effective treatment option to help treat Ar’Tee’s dry eye disease. Once Ar’Tee started twice-daily Xiidra, he began feeling symptom relief at 2 weeks.”
- Dr. Davison
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. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. Data on file. Panel-based Chart Review of Patients with DED Receiving Xiidra in the US and Canada. Novartis Pharmaceuticals Corp; Nov. 2020.
References
- 1. Data on file. DRF Fingertip Formulary® Novartis Pharmaceutical Corp; July 2022.
- 2. Data on file. DRG Fingertip Formulary® incorporating Payer Sciences business rules as of January 18, 2022.
- 3. Data on file. IQVIA Dry Eye OTC Analysis. November 2018 to October 2019. Novartis Pharmaceuticals Corp: April 2020.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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.
- 3. 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.
- 4. 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.
- 5. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II Pathophysiology Report. Ocul Surf. 2017;15(3):438-510.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017;15(3):539-574.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276-283.
References
- 1. Akpek EK, Amescua G, Farid M, et al. Dry Eye Syndrome Preferred Practice Pattern®. Ophthalmology. 2019;126:286-334.
- 2. Starr CE, Gupta PK, Farid M, et al. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019;45(5):669-684.
- 3. Trattler WB, Majmudar PA, Donnenfeld ED, et al. The Prospective Health Assessment of Cataract Patients’ Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017;11:1423-1430.
- 4. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 5. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15(3):276-283.
- 6. Matossian C, McDonald M, Donaldson K, et al. Dry eye disease: consideration for women’s health. J Women’s Health. 2019;28(4):502-514.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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.
- 3. 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.
- 4. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II Pathophysiology Report. Ocul Surf. 2017;15(3):438-510.
Reference
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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.
- 3. 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.
- 4. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15(3):438-510.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. Data on file. SHP606-304. OPUS-3 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2015.
- 3. Data on file. TRA100773A. PHASE II Clinical Study Report. Novartis Pharmaceuticals Corp; October 2007.
- 4. Data on file. 1118-KCS-200. OPUS-1 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2013.
- 5. Data on file. 1118-DRY-300. OPUS-2 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2014.
- 6. Semba CP, Torkildsen GL, Lonsdale JD, et al. A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye. Am J Ophthalmol. 2012;153(6):1050-1060.e1.
- 7. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017;15(3):539-574.
- 8. Miller KL, Walt JG, Mink DR, et al. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010;128(1):94-101.
- 9. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575-628.
- 10. 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.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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.
- 3. Data on file. 1118-KCS-200. OPUS-1 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2013.
- 4. Data on file. 1118-DRY-300. OPUS-2 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2014.
- 5. Data on file. SHP606-304. OPUS-3 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2015.
- 6. 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 Ophthal. 2019;29(4):394-401.
References
- 1. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II Pathophysiology Report. Ocul Surf. 2017;15(3):438-510.
- 2. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15(3):276-283.
- 3. 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
- 4. 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.
- 5. US Food and Drug Administration. FDA approves new medication for dry eye disease. Published July 12, 2016. Accessed January 21, 2022. https:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=349&showFR=1
- 6. Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628.
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. 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.
References
- 1. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II Pathophysiology Report. Ocul Surf. 2017;15(3):438-510.
- 2. Akpek EK, Amescua G, Farid M, et al. Dry Eye Syndrome Preferred PracticePattern®. Ophthalmology. 2019;126(1):286-334.
- 3. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15(3):276-283.
- 4. 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.
- 5. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
Reference
- 1. Data on file. Panel-based Chart Review of Patients with DED Receiving Xiidra in the US and Canada. Novartis Pharmaceuticals Corp; Nov. 2020.
Reference
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
Reference
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
Reference
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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.
References
- 1. Xiidra [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020.
- 2. 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
- 3. 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.
- 4. 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.
- 5. 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.
- 6. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15(3):438-510.
- 7. Donnenfeld ED, Perry HD, Nattis AS, Rosenberg ED. Lifitegrast for the treatment of dry eye disease in adults. Expert Opin Pharmacother. 2017;18(14):1517-1524.
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
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.