Do some of your patients with dry eye disease deserve a change?
IN THIS SECTION
Do some of your patients with dry eye disease deserve a change?
In a previous survey, how many millions of Americans were estimated to be diagnosed with dry eye disease?
In 2016, how many dry eye disease patients were estimated to be treated with a prescription?
Between 2005 and 2012, how much did the prevalence of dry eye disease increase?
FOOTNOTES
*Due to combination use, the number of patients treated
by prescription will overstate the actual number of treated patients. Data were compiled
by Jefferies Equity Research analysts employed in the United States by Jefferies LLC, a
firm registered with the Securities and Exchange Commission and a member of the Financial
Industry Regulatory Authority, Inc. Jefferies does and seeks to do business with companies
covered in its research reports. As a result, investors should be aware that Jefferies may
have a conflict of interest that could affect the objectivity of this report.
†Retrospective analysis to assess overall prevalence,
annual prevalence, and incidence of DED using the DOD MHS data on beneficiary
medical claims from US DOD military and civilian facilities from January 1, 2003, through
March 31, 2015. Analysis (2005-2012) was conducted on a total of 9,732,272 MHS beneficiaries, aged
2-80+. The analysis of prevalence and incidence was estimated based on ICD-9 and current
procedural terminology (CPT) codes and prescription fills.
DOD=Department of Defense, MHS=Military Health System.
*Due to combination use, the number of patients treated by prescription will overstate the actual number of treated patients. Data were compiled by Jefferies Equity Research analysts employed in the United States by Jefferies LLC, a firm registered with the Securities and Exchange Commission and a member of the Financial Industry Regulatory Authority, Inc. Jefferies does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that Jefferies may have a conflict of interest that could affect the objectivity of this report.
†Retrospective analysis to assess overall prevalence, annual prevalence, and incidence of DED using the DOD MHS data on beneficiary medical claims from US DOD military and civilian facilities from January 1, 2003, through March 31, 2015. Analysis (2005-2012) was conducted on a total of 9,732,272 MHS beneficiaries, aged 2-80+. The analysis of prevalence and incidence was estimated based on ICD-9 and current procedural terminology (CPT) codes and prescription fills.
DOD=Department of Defense, MHS=Military Health System.
Dry eye disease is a multifactorial disease that may be progressive and chronic.
Some patients may require more than artificial tears.4-9
Inflammation: a possible underlying cause of dry eye disease8
The American Academy of Ophthalmology suggests that inflammation may be an underlying cause of your patient's dry eye disease. Dry eye disease can be triggered by a variety of proposed factors, including7,8,10:
Contact lenses
Antihistamines
Prolonged device
time
Sex (women may be at higher risk)
Aging
Low humidity,
cold,
or windy places
Changes in
hormones
Reading a lot
Xiidra is indicated for the treatment of signs and symptoms of dry eye disease, which can include meibomian gland dysfunction as a cause.6,7,11‡
‡Xiidra is an LFA-1 antagonist for the treatment of dry eye disease.11
Inflammation: a possible underlying cause of dry eye disease8
The American Academy of Ophthalmology suggests that inflammation may be an underlying cause of your patient’s dry eye disease. Dry eye disease can be triggered by a variety of proposed factors, including7,8,10:
Contact lenses
Antihistamines
Prolonged
device
time
Sex (women may be at higher risk)
Aging
Low humidity,
cold, or windy
places
Changes in
hormones
Reading a lot
Xiidra is indicated for the treatment of signs and symptoms of dry eye disease, which can include meibomian gland dysfunction as a cause.6,7,11‡
‡Xiidra is an LFA-1 antagonist for the treatment of dry eye disease.11
Common symptoms of dry eye disease8
If your patients are experiencing persistent dry eye symptoms and artificial tears aren’t enough, consider prescribing Xiidra, which was designed to target a source of underlying inflammation that may fuel dry eye disease.4-6,11-13§
§Xiidra blocks LFA-1 on T cells from binding with ICAM-1 that may be overexpressed on the ocular surface in dry eye disease and may prevent formation of an immunologic synapse which, based on in vitro studies, may inhibit T cell activation, migration of activated T cells to the ocular surface, and reduce cytokine release. The exact mechanism of action of Xiidra in dry eye disease is not known.6,11,12
Xiidra may provide lasting symptom relief
in as early as 2 weeks11¶
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 studies.11
¶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.11
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.