Thought leader perspectives
Experts in the field share their opinions on discussion of the signs and symptoms of dry eye disease with patients, diagnostic methods, and a treatment for dry eye disease that can bring patients symptom relief.
IN THIS SECTION
Approaching DED in Presurgical Patients
Discover his preferred treatment and management plan for DED in patients who are presenting for surgery, from Dr. Richard Lindstrom, Founder and Attending Surgeon Emeritus at Minnesota Eye Consultants, Chief Medical Officer and Board Member at TLC Laser Eye Centers, Senior Lecturer and Trustee Emeritus of the Foundation at the University of Minnesota and Visiting Professor at the UC Irvine Gavin Herbert Eye Institute. Dr. Lindstrom is a paid consultant for Novartis.
Xiidra in his practice
An early adopter of Xiidra and Novartis employee, Dr. Jay K Mattheis shares key steps to successful patient communication in his practice, and the importance of prior authorizations.
Improvement in signs of dry eye disease can be possible
Xiidra® improved signs (based on ICSS) of dry eye disease at
12 weeks in 3 out of 4 studies.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.