How I approach DED in my presurgical patients
Clinical Commentary From Dr. Richard L. Lindstrom
Richard L. Lindstrom, MD, is the 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. He is a board-certified ophthalmologist and internationally recognized leader in cornea, cataract, refractive surgery, glaucoma, laser surgery, innovation, investment, and the business of ophthalmology. He has been at the forefront of ophthalmology’s evolutionary changes throughout his 52-year career in medicine as a clinician, leader, researcher, teacher, inventor, writer, industry consultant, and highly acclaimed physician and surgeon. Dr. Lindstrom is a paid consultant for Novartis Pharmaceuticals Corporation, the maker of Xiidra.


Richard L. Lindstrom, MD
Founder and Attending Surgeon Emeritus at Minnesota Eye Consultants
Chief Medical Officer and Board Member at TLC Laser Eye Centers
Taking Care of Ophthalmic Surgery Patients With DED
In my decades-long career as an ophthalmic surgeon, I have come to appreciate the importance of identifying and treating dry eye disease (DED) in my cataract and refractive patients. Standard ocular surface parameters commonly performed prior to surgery can help identify some of these patients. Therefore, all patients undergoing cataract surgery in my practice are evaluated and managed for dry eye preoperatively.1,2
In my clinical practice, I stress the importance of treating dry eye before surgery. I also emphasize the continuum of care for the dry eye patient, since this is a chronic condition.1,2
The incidence of DED in cataract surgery candidates who are asymptomatic was found to be higher than previously thought, according to a few different studies.2 In a 2017 prospective study of 136 patients 55 years and older who were scheduled to have cataract surgery and who completed a dry eye signs and symptoms questionnaire, the majority (69.1%) reported no stinging and burning and 63.2% were never affected by the symptom of dryness. Despite this, 209 eyes (76.8%) had positive fluorescein corneal staining scores.3 This helps support that screening for DED in these surgical patients is important.
In this blog, I will explain my preferred regimen for treating and managing the continuum of dry eye disease in patients presenting for surgery.
Proper management of the ophthalmic surgery patient with DED is an essential part of ocular surface preparation prior to surgery, and it is also important to ensure the continuum of care for the patient after surgery.
Ocular Surface Preparation Before Surgery
In my opinion, an effective DED therapy prior to surgery is an important aspect of presurgical management for both the surgeon and the patient. As we may know, research tells us that inflammation plays a role in the pathogenesis of dry eye disease. Therefore, it may often be addressed with a topical steroid as monotherapy for an appropriate duration based on an individual patient’s management plan.
According to the ASCRS algorithm for the preoperative diagnosis and treatment of ocular surface disorders, treatment in the preoperative setting should minimally start at Step 2 of the TFOS DEWS II treatment guidelines.
In my practice, I hope to improve inferior corneal staining. Since the inflammation with dry eye disease isn’t always temporary, use of an LFA-1 antagonist like Xiidra may be necessary as it targets a source of inflammation in DED.4 This aligns with the ASCRS guidelines, which recommend instituting therapy as far in advance of surgery as possible.2
Providing Continuous Care for DED Patients
I believe a patient who has a significant level of DED should continue to be under the care of an Eye Care Provider (ECP) following surgery.
In my busy ophthalmic practice, continuous care of the DED patient is often delegated to a colleague, which might be a medical ophthalmologist, optometrist, or physician’s assistant. Nonetheless, I consider it my responsibility to educate the patient regarding their chronic DED condition and recommend appropriate DED therapy.1 I may then refer the patient to an appropriate provider if I choose not to manage the patient myself.
Keeping an Eye on Your DED Patients
Paying close attention to ocular surface preparation prior to surgery is something I encourage my ECP colleagues to embrace. The recognition of the chronic and potentially progressive nature of DED is equally important for the provider and patient to ensure appropriate care for the patient.1,5,6
In my opinion, it is important for the ophthalmic surgeon to appropriately manage and treat patients presenting with dry eye disease prior to surgery and ensure patients are continually managed by an ECP following surgery. It is helpful to periodically reassess the patient’s compliance and understanding of the disease, the potential benefits of treatment and complications, and to re-educate the patient as necessary. The patient and physician together can establish realistic expectations for effective management of dry eye disease.1
Fewer signs of dry eye disease can be possible
Xiidra improved signs (based on ICSS) of dry disease at 12 weeks in 3 out of 4 studies 1
Xiidra® may provide lasting symptom relief in as early as 2 weeks1*
Xiidra reduced symptoms of eye dryness (based on EDS) at 2 weeks in 2 out of 4 studies, with improvements observed at 6 and 12 weeks in all 4 studies1.
*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 Eye Dryness Score [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
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.