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CEQUA® Is How You and Your Patients See Eye to Eye

Paul M. Karpecki, OD, FAAO

Paul M. Karpecki, OD, FAAO

This post is sponsored by Sun Ophthalmics
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Paul Karpecki, OD, FAAO, explains how CEQUA® (cyclosporine ophthalmic solution) 0.09% can increase tear production in patients with dry eye disease. He also covers the drug’s indication, dosing, and potential adverse reactions as well as the importance of fast, comfortable results. 

CEQUA® is a 0.09% cyclosporine solution. An immunosuppressant, cyclosporine acts by inhibiting calcineurin (a protein phosphatase which activates T cells), which is what allows CEQUA to increase tear production in patients with dry eye disease or keratoconjunctivitis sicca.1

Dry eye disease has huge economic impact

According to estimates, the total cost for management of DED in the United States is about $3.84 billion2 based on 30 million people in the US suffering from the condition.3-5 Considering the face of DED is changing and affecting younger patients, this means that eyecare professionals are looking at 6 to 7 million patients between the ages of 18 and 34 who are suffering from immune-mediated dry eye disease.6 Compared to glaucoma, dry eye affects about ten times the amount of people, putting a burden on busy optometric practices.
Burden of DED

Fast relief is a priority*

Ultimately, patients want a drop that provides:
  • Rapid symptom relief7-9
  • Tolerability9-12
  • Fast onset of action on underlying disease
One of the main obstacles in treating DED is that there is often an overall low adherence rate when it comes to anti-inflammatory drops. Side effects like burning and stinging may cause a patient to stop using the drop.12 A majority of patients using Xiidra® (lifitegrast ophthalmic solution) 5% and Restasis® (cyclosporine ophthalmic emulsion) 0.05% discontinue treatment within one year.13
*CEQUA delivers results as early as two weeks.21

Safety data for CEQUA

In general, 95% of CEQUA patients experience no or mild instillation site discomfort.14,15,a,b
  • 78.2% of patients had no instillation site pain (including burning and stinging)1
  • 17.4% had mild symptoms1
  • 3.6% had moderate symptoms1
  • 0.8% of patients had severe instillation site pain1
The most common adverse reactions reported in greater than 5% were pain on instillation of drops (22%) and conjunctival hyperemia (6%). To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.
a Instillation site pain included burning and stinging.14,15
b. The first time they tried CEQUA, 9 out of 10 patients reported no or mild discomfort after 3 minutes.16

How is CEQUA different?

CEQUA is a 0.09% cyclosporine ophthalmic solution, which is a higher concentration than other cyclosporine concentrations like Restasis (0.05%). What makes CEQUA different is that it’s a novel formulation that encapsulates, penetrates and delivers cyclosporine directly to ocular tissue in a formulation that is tolerable and effective for patients.

What makes the CEQUA vehicle unique?

CEQUA is formulated with ingredients encapsulated in an unpreserved, isotonic, neutral pH vehicle using innovative naomicellar technology—or NCELL® for short.17 This is important, as one of the major issues in the past with cyclosporine is that it is non-water-soluble. NCELL technology encapsulates the cyclosporine in tiny spheres, which penetrate the aqueous layer of the tear film.17-20
NCELL Formulation Provides Up to 3x Higher CsA Absorption Over Cyclosporine Emulsion 0.05%

What should you tell patients about CEQUA?

  1. CEQUA delivers results as early as two weeks (improved total corneal staining data)21
  2. CEQUA achieved a statistically significant reduction in total corneal staining at one month compared to vehicle14-16
  3. Patients reported a meaningful reduction in symptom severity by day 2814

Visual acuity results after CEQUA use

Clinical data reveals improvements in visual acuity correlated with reduced central corneal staining as early as Day 56.15,22 Not only did the pivotal study demonstrate significant central corneal clearing or stain reduction, it also translated to better visual acuity.
After 3 months, results showed that 65% of central corneas were completely clear for patients taking CEQUA.15 In this study, 38.3% of patients had complete corneal staining at baseline, so a jump to 65% is significant, especially with a P value of less than 0.02.15 This is a particularly meaningful result as one of the symptoms of dry eye disease is blurry vision.

Nearly double the tear production1

More CEQUA patients experienced a clinically meaningful improvement in tear production at 3 months (>10mm change from baseline in Schirmer test score) compared to vehicle across two studies.1

Patients who switched from Restasis to CEQUA

Last year, a Phase 4 single-arm, open-label study was conducted on patients who switched from Restasis to CEQUA.23 The study revealed that 69% of patients preferred CEQUA over Restasis. Researchers found that CEQUA showed improvements from baseline in central corneal staining as early as 4 weeks and in modified Symptom Assessment in Dry Eye (mSANDE) scores in patients with DED whose disease was uncontrolled on Restasis therapy.23
Adverse Events were consistent with the safety profile seen in pivotal trials, and no new safety signals were observed.

CEQUA patients stayed on treatment longer than patients receiving Xiidra or Restasis

A real-world longitudinal cohort study showed that after nearly a year (360 days), more patients were still using CEQUA® than Restasis® and Xiidra®:24
Median treatment duration:
  • CEQUA: 11.6 months24
  • Xiidra: 8.8 months24
  • Restasis: 7.9 months24
Study design: Real-world, retrospective, longitudinal cohort study utilizing data from the Symphony Health Integrated Dataverse (IDV), a national provider-based claims database, examining time to treatment discontinuation, probability of treatment discontinuation, and treatment persistence among patients with DED treated with CEQUA (n=1846), Restasis (n=2248), or Xiidra (n=3008).24

CEQUA has affordability options

Through a partnership with PhilRx, if optometrists send prescriptions to the PhilRx pharmacy, a patient will receive the lowest possible pricing for CEQUA based on their medical insurance. For some patients, that can be a $30 copay, but for others it could be a $0 copay. This is a wonderful opportunity which can benefit many patients seeking relief from dry eye symptoms.
Learn more about CEQUA at www.cequapro.com.
© 2024 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved.CEQUA, and NCELL are registered trademarks of Sun Pharmaceutical Industries Limited.
All other trademarks are the property of their respective owners

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

ADVERSE REACTIONS
The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please see the Full Prescribing Information.


1. CEQUA [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2022.
2. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017;15(3):334-365. doi:10.1016/j.jtos.2017.05.003
3. Farid M. Dry Eye Disease: Let's Start Thinking Outside of the Artificial Tear Box. Ophthalmology. 2017;124(11S):S1-S3. doi:10.1016/j.ophtha.2017.07.021
4. Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the beaver dam offspring study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799-806. doi:10.1016/j.ajo.2013.12.023
5. Epstein A, Karpecki P, Mastrota K, Whitley W. Dry Eye Disease. What We Know About It Today and Its Importance for Optometry. Supplement: Review of Optometry. 2016.
6. 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. doi:10.1016/j.ajo.2017.06.033
7. Asbell P, Messmer E, Chan C, Johnson G, Sloesen B, Cook N. Defining the needs and preferences of patients with dry eye disease. BMJ Open Ophthalmol. 2019;4(1):e000315. Published 2019 Dec 5. doi:10.1136/bmjophth-2019-000315
8. Cook NS, Cave J, Holtorf AP. Patient Preference Studies During Early Drug Development: Aligning Stakeholders to Ensure Development Plans Meet Patient Needs. Front Med (Lausanne). 2019;6:82. Published 2019 Apr 24. doi:10.3389/fmed.2019.00082
9. Messmer E, Chan C, Asbell P, Johnson G, Sloesen B, Cook N. Comparing the needs and preferences of patients with moderate and severe dry eye symptoms across four countries. BMJ Open Ophthalmol. 2019;4(1):e000360. Published 2019 Dec 15.
10. Ozdemir S, Yeo SWJ, Lee JJ, Bhaskar A, Finkelstein E, Tong L. Patient Medication Preferences for Managing Dry Eye Disease: The Importance of Medication Side Effects. Patient. 2022;15(6):679-690. doi:10.1007/s40271-022-00586-8
11. Saldanha IJ, Petris R, Han G, Dickersin K, Akpek EK. Research Questions and Outcomes Prioritized by Patients With Dry Eye. JAMA Ophthalmol. 2018;136(10):1170-1179. doi:10.1001/jamaophthalmol.2018.3352
12. Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis(®) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-1976. doi:10.2147/OPTH.S30261
13. White DE, Zhao Y, Ogundele A, et al. Real-World Treatment Patterns Of Cyclosporine Ophthalmic Emulsion And Lifitegrast Ophthalmic Solution Among Patients With Dry Eye. Clin Ophthalmol. 2019;13:2285-2292.
14. Data on file. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.
15. Goldberg DF, Malhotra RP, Schechter BA, Justice A, Weiss SL, Sheppard JD. A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease. Ophthalmology. 2019;126(9):1230-1237.
16. Tauber J, Schechter BA, Bacharach J, et al. A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthalmol. 2018;12:1921-1929.
17. US Patent 9,937,225 B2.
18. Cholkar K, Gilger BC, Mitra AK. Topical, Aqueous, Clear Cyclosporine Formulation Design for Anterior and Posterior Ocular Delivery. Transl Vis Sci Technol. 2015;4(3):1. Published 2015 May 1. doi:10.1167/tvst.4.3.1
19. Mandal A, Bisht R, Rupenthal ID, Mitra A. Polymeric micelles for ocular drug delivery: from structural frameworks to recent preclinical studies. J Control Release. 2017;248:96-116.
20. Cholkar K, Patel A, Vadlapudi AD, Mitra AK. Novel nanomicellar formulation approaches for anterior and posterior segment ocular drug delivery. Recent Pat Nanomed. 2012;2(2):82-95.
21. Schechter BA, Urbieta M, Bacharach J, et al. Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial. Clin Ophthalmol. 2022;16:4145-4151. Published 2022 Dec 13. doi:10.2147/OPTH.S392315
22. Malhotra R, Devries DK, Luchs J, et al. Effect of OTX-101, a novel nanomicellar formulation of cyclosporine a, on corneal staining in patients with keratoconjunctivitis sicca: a pooled analysis of phase 2b/3 and phase 3 studies. Cornea. 2019;38:1259-1265.
23. Johnston, J. Effect of OTX-101 0.09% on corneal staining and SANDE scores in patients with dry eye disease uncontrolled on cyclosporine ophthalmic emulsion 0.05%. Abstract presented at American Academy of Optometry 2023; October 12, 2023; New Orleans, LA.
24. Karpecki P, Barghout V, Schenkel B, et al. Real-world treatment patterns of OTX-101 ophthalmic solution, cyclosporine ophthalmic emulsion, and lifitegrast ophthalmic solution in patients with dry eye disease: a retrospective analysis. BMC Ophthalmol. 2023;23(1):443. Published 2023 Nov 2. doi:10.1186/s12886-023-03174-y
Paul M. Karpecki, OD, FAAO
About Paul M. Karpecki, OD, FAAO

Paul M. Karpecki, OD, FAAO, received his doctor of optometry degree from Indiana University and completed a Cornea Fellowship in Kansas City, in affiliation with the Pennsylvania College of Optometry. He currently serves as Director of Cornea and External Disease at Kentucky Eye Institute in Lexington KY and as an Associate Professor at the Kentucky College of Optometry at the University of Pikeville.

Dr. Karpecki was appointed to the Delphi Dry Eye International Society that includes the top 25 dry eye experts in the world, the Tear Film and Ocular Surface (TFOS) DEWS II Diagnostic Methodology sub-committee and co-chair for the previous two TFOS Symposia.

To put Dr. Karpecki’s practice in perspective, most of the top dry eye centers in the country have 20-50 Sjogren’s Syndrome KCS patients; Dr. Karpecki has over 800 positive-diagnosed Sjogrens’ Syndrome patients under his direct care. He is the Chief Medical Editor for Review of Optometry and is on the board of the charitable organization Optometry Giving Sight.

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IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.
Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.
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