EDS was rated by patients using a visual analogue scale (0=no discomfort, 100=maximal discomfort)
at each study visit.
Across all 4 Xiidra pivotal studies, average baseline EDS was 40-70.1
Based on analysis of covariance (ANCOVA) model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra-treated subject who did not have a baseline value was excluded from analysis.1
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).1
The signs of dry eye disease
Xiidra was evaluated for its impact on the signs of dry eye disease in 4 robust clinical trials.1
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 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.